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 contin ued product development, NON IN reserves the
right to make changes and improvements to this manual and the products it
describes at any time, without notice or ob l igation.
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
mail@nonin.com
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 w ord mark and logos are owned by th e Bluetoo th 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.
Detailed information for functional symbols can be found in “Using the
Avant 4000 Digital Pulse Oximetry System.”
Regulatory Symbols
S
A
L
C
U
C
SN
!
I
F
L
I
E
D
U
0123
Attention: See Instructions for Use or related
materials.
Type BF Applied Part
(Patient isolation f r om electrical shock).
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 tran smitters; interference
may occur in the vicinity of equipment marked
with this symbol.
1
Page 5
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 e quipment.
To av oid 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 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
Page 6
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 SpO
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 SpO
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. Pa tient sensitivity to sensors may v ary 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.
2
accuracy.
2
3
Page 7
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 operati on.
•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 fo llowing
measures: (1) Reorient or relocate the receiving ant enna, (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 th e rec ei v er is connected, or (4) Co nsult 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/OE T
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 accessorie s 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
Page 8
Manufacturer’s Declaration
Refer to the following table for specific information regarding this device’s
compliance to IEC Standard 60601-1-2.
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
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Group 2This device must emit electromagnetic
Class BThis device is suitable for use in all estab-
A
N/A
energy in order to perform its intended
function. Nearby electronic equipment may
be affected.
lishments, including domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
5
Page 9
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:
• Av ant 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 NONI N® 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 patien ts. It is indicated for spot
checking and/or continuous monitoring.
™
The Avant 4000 Digital Pulse Oximetry System: Display Unit and Patient Module.
6
Page 10
General Information about Bluetooth Technology
Bluetooth is a technology that enables automatic wireless connections between a
variety of electronic comm un icatio ns and comp uting devi ces, 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 v o ic e, 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 SpO
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 radiu s).
The display unit has a minimum ope rating battery life of 18 hours.
, pulse rate, and
2
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 detect able by any other Bluetooth-enabled devi ce,
which reduces the risk of interference and preserves data integrity.
7
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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—be i ng careful not to over-tighten.
8
Page 12
Installing Batteries in the Patient Module
9
Page 13
Using the Avant™ 4000 Digital Pulse Oximetry System
1
3
1415
13
12
1617
™
20
18
1Main Alarm LED
2Alarm Silence LED
3Numeric LEDs for %SpO2 data
4Pulse Oximeter Sensor LED
5Pulse Strength Bargraph LED
6Pulse Quality LED
7Numeric LEDs for Pulse Rate data
8Alarm Silence Button
9Alarm Limits Button and Indicator
10Plus Button
11Minus Button
12Time LED
13Month LED
4
5
6
21
2223
2
7
19
25
24
8
9
10
11
26
14Day LED
15Year LED
16Pulse Volume LED
17Alarm Volume LED
18Connection Status LED
19Remote Battery Status LED
20Bluetooth Control Button
21Memory Button
22Time/Date Button
23Volume Button
24AC Power Adapter LED
25Battery LED
26ON/STANDBY Button
10
Page 14
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 bl ood 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 disp l ay in green. For high
priority (patient) alarms, the corresp onding 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 even t 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.
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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 th e 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 Alar m 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.
12
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 SpO
display area. While fi v e
2
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 avai lable 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, pres sing the Bluetooth Control button
displays the selected patient module’s device identification number
for three seconds in the pulse rate and SpO
display area. See “Device
2
Pairing” for more information.
Page 16
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 amb er.
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
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Using the Avant™ 4000 Digital Pulse Oximetry System
Alarm Volume LED
This amber LED indicates that the Alarm V olume can be revi ewed 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.
14
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 ch arge/disch arge/recharge cycl e 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.
Page 18
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 availa ble. 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
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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:If desired, any excess strap material may be trimmed and
discarded.
16
Page 20
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: V erify all alarm settings during system startup to ensure that
they are set as intended.
Use the procedure below to mo nitor SpO
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.V erify that a good SpO
and that the Pulse Strength Bargraph LED is active.
reading is displayed, that a pulse rate value appears,
2
and pulse rate readings in order to verify
2
17
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Using the Avant™ 4000 Digital Pulse Oximetry System
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
and Pulse Rate display areas as the system searches for patient modules
SpO
2
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 displaye d separatel y, with the device identification
number appearing in the SpO
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 yo u 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.
and Pulse Rate display areas. (A unique device
2
NOTE: After the display unit is paired to a patient module, it will remain
paired until the above process is repeated.
18
Page 22
Default Settings
The Avant 4000 display unit features Factory Default and User-Defined Default
settings.
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 availa ble. DO NOT
use the device without batteries when patient safety relies
upon audible alarms.
CAUTION: V erify all alarm settings during system startup to ensure that
they are set as intended.
Factory Default Setting
In Factory Default setting, all adjustable alarm and volume parameters are set at
their default values. F actory Default setting is the system’ s default operating setting.
It is indicated by DIP switch 8 in the DOWN position. For more information about
default alarm values, refer to this manual’s “Alarms and Limits” section.
NOTE: Any alarm and volume adjustments made while the device is
operating in Factory Default Setting will be lost when the device is
shut down. The last adjusted values can be recalled by pressing
and holding both the Alarm Limits and ON/STANDBY buttons
when turning on the display unit.
User-Defined Default Setting
In User-Defined Default Setting (DIP switch 8 in the UP position), alarm limit
settings must be adjusted. When this setting is first activ ated, valid limit settings must
be entered for SpO
operating mode until all limits have been set. Once set, the adjusted values are used
as defaults until the system is turned on with DIP switch 8 in the DOWN position,
at which time the device restarts in Fa ctory Default setting.
and pulse rate alarm limits; the system will not return to normal
2
NOTE: In order to initiate User-Defined Defaults, the unit must be turned
on with DIP switch 8 in the UP position.
NOTE: Once User-Defined Default Settings are entered, any alarm and
volume adjustments made while operating the device will be lost
when the device is shut down.
19
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Using the Avant™ 4000 Digital Pulse Oximetry System
Accessing User Functions
This system includes Basic, Set, and Advanced Functions.
Basic Functions
Basic functions are generally easy to use and involve only a single button. The Avant
4000 display unit has several basic functions.
FunctionButtonInstruction
Turn the display unit
on and off.
Check the battery
charge.
Mute the audible
alarms (2 minutes—
toggle).
Adjust the
display intensity
(brightness).
View the patient module identification number currently in use.
Invoke the print-ondemand feature.
Press the ON/STANDBY button
to turn on the display unit. Press
and hold the button for at least one
second to turn off the display unit.
Press the ON/STANDBY button
while the unit is on. Battery charge
is displayed (in 10% increments, for
4 seconds in green) on the Pulse
Strength Bargraph.
Press the Alarm Silence button.
Press the Plus or Minus button.
or
™
Press the Bluetooth Control button
during normal operation.
With DIP switch 4 in the DOWN
position, press the ON/
STANDBY button.
Invoke the event
marker.
20
Press the ON/STANDBY button
during real-time printing.
Page 24
Set Functions
Set functions are those that require multiple buttons to alter a measurement or
device parameter for normal operation.
FunctionButtonInstruction
Set alarm limits.Press the Alarm Limits button to
step through the Limits menu.
then
or
Use the Plus or Minus buttons to
adjust alarm limits.
Set pulse and
alarm volumes.
Press the Volume button to select
pulse or alarm volume. Use the
Plus or Minus buttons to adjust
then
or
the selected volume.
Set time and date.Press the Time/Date button to
step through the Time/Date
menu. Use the Plus or Minus
then
or
buttons to adjust the time and
date values.
21
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Using the Avant™ 4000 Digital Pulse Oximetry System
Advanced Functions
Advanced functions are restricted to trained users; they require multiple button
presses in order to prevent acc i dental activation.
FunctionButtonInstruction
Pair DevicesPress and hold the Bluetooth Control
™
button while turning on the display unit. A
maximum of five “pairable” patient
+
modules will be displayed, with the device
identification number appearing in the
pulse rate and SpO
display areas.
2
When the desired patient module’s
identification number is displayed, pressing
the Bluetooth Control button completes
the pairing process.
Retain
Previous UserDefined Alarm
Limit Settings
Enter Patient
Playback and
Memory Clear
Menu
+
+
Press and hold both the Alarm Limits and
ON/STANDBY buttons when turning on
the display unit.
Press and hold the Memory button while
turning on the display unit. This menu
functions with NONIN’s nVISION
software.
®
22
Page 26
Display Unit DIP switches
The Avant 4000 display unit contains eight DIP switches that are located behind the
back cover of the unit. The UP position is to ward the top of the unit, and the
DOWN position is tow ard the bottom of the unit. The factory setting for all DIP switches
is the DOWN position.
SwitchFunction
Switch 1Reserved for Future Use
Switch 2Alarm Disable Lock
Up—Alarm volume may be disabled
Down—Alarm volume cannot be disabled
Switch 3Date Format
Up—International Date format (Day-Month-Year)
Down—U.S.A. Date format (Month-Day-Year)
Switch 4Data Output
Up—Real-time (once per second) data output
Down—Print on demand
Switch 5Normal / Fast Responding SpO
Up—Fast responding SpO
Down—Normal SpO2 serial output
Up—User-Defined Defaults for Alarm Limits and Volume Settings
Down—Factory Defaults for Alarm Limits and Volume Settings
Output
2
serial output
2
12
5
6
78
3
4
23
Page 27
Using the Avant™ 4000 Digital Pulse Oximetry System
Nurse Call Feature
The Avant 4000 features a Nurse Call circuit that can be connected to a hospital
nurse call system, allowing al arm conditions to be recognized at a central monitoring
location and on the Avant 4000.
DIP switch 7 allows users to select the duration output of a signal. In the DOWN
position, a one-second signal is output when an audible alarm starts. In the UP
position, the nurse call signal is active during the entire duration of an audible alarm.
Included in the Nurse Call Circuit is a switch—located on the base of the back panel
and covered by the back cover to prevent acci de ntal toggling—that allows users to
select NO (Normally Open—the left position) or NC (Normally Closed—the right
position). (See “Installing the Batteries” for instructions on removing the back
cover .) The Nurse C all Circui t can be us ed both when the Avant 4000 is plugged in
and when it is running on battery power.
Nurse Call
Connection
RS232 Serial
Connection
Power
Connection
Nurse Call
Switch
Relay Channel Selected
Normal
Operation
Alarm
Condition
Normally Open (NO)OpenClosedOpen
Normally Closed (NC)ClosedOpenClosed
WARNING: It is the user’s responsibility to implement the interface
between the Nurse Call system and the Avant 4000, and to
adequately test the interface between the 4000 and the Nurse
Call system to ensure that the desired function is operational.
24
Off
Page 28
Care and Maintenance
The advanced digital circuitry within the pulse o ximeter of this system requires no
calibration or periodic maintenance other than battery replacement.
Field repair of system circuitry is not possible . Do no t attempt to open the case or
repair the electronics. Opening the case will damage the unit and void the warranty.
If the system is not functioning properly, see “Troubleshooting.”
Cleaning the Avant 4000 Digital Pulse Oximetry System
Clean all system components with a soft cloth dampened with isopropyl alcohol. Do
not pour or spray any liquids onto co mponents, and do not allow any liquids to enter
any openings in the device. Allow the unit to dry thoroughly before reuse.
IMPORTANT! Do not immerse the device in liquid, and do not use
caustic or abrasive cleaning agents on the device.
Clean the device separately from its associated sensors. For instructions regarding
cleaning pulse oximeter sensors, refer to the appropriate pulse oximeter sensor
package inserts.
25
Page 29
Alarms and Limits
Alarms and Limits
This chapter describes alarms and limits for the Avant 4000 Digital Pulse Oximetry
System.
Alarms and Informational Tones
The Avant 4000 display unit provides high and medium priority audible and visual
alarms, as well as informational tones.
High Priority Alarms
High priority alarms are those that require immediate attention to the patient. They
include SpO
alarms are indicated with rapidly blinking red LED displays when alarm limits are
met or exceeded. In addition, the pulse strength bargraph LED may illuminate a red
segment to indicate low perfusion.
High priority alarms are sounded as follows: “beep, beep, beep,” (short pause),
“beep, beep” (10-second pause).
Medium Priority Alarms
Medium priority alarms are those that signal potential problems with the equipment
or other non-life-threatening situations. On the display unit, medium priority alarms
are indicated with slowly blinking amber displays.
pulse rate, and low perfusion alarms. On the display unit, high priority
2,
Medium priority alarms are illuminated amber on the Main Alarm LED and on the
appropriate indicator(s) or numeric displays, some times displa yi ng an error code to
help the user identify the source of the error.
Medium priority alarms are soun ded as follows: “beep, beep, beep,” (25-second
pause), “beep, beep, beep.”
Informational Tones
Informational tones communicate important information. They are typically single
“beeps” or a series of three “beeps.” Informational tones includ e th e startup/
initialization tone and the pulse rate tone (which changes in pitch with SpO
values).
2
26
Page 30
Alarm Summary
If patient SpO2 or pulse readings are equal to or above the upper alarm limit, or if
they are equal to or below the lower alarm limit, the display unit will signal an alarm.
Factory
High Priority Alarm Description
Upper Alarm LimitOffOff, 80 to 1001% SpO2
SpO
2
SpO2 Lower Alarm Limit80%Off, 50 to 951% SpO2
Pulse Upper Alarm Limit200 BPMOff, 75 to 275 5 BPM
Pulse Lower Alarm Limit50 BPMOff, 30 to 110 5 BPM
DefaultAdjustment Range Step Value
Silencing Alarms
Momentary (2-Minute) Alarm Silence
To silence alarms for two minutes, press the Alarm Silence button.
Continuous Alarm Silence
In order to permanently silence all alarms, DIP switch 2 must be placed in the UP
position. This allows the alarm volume to be set to zero. The Alarm Silence LED will remain illuminated when the alarm volume is set to zero. Refer to “DIP Switches” for more
information.
27
Page 31
Alarms and Limits
Adjusting Volume and Alarm Limits
Follow the instructions below to review, set, or adjust volumes and alarm limits while
operating the Avant 4000 System. Do not use these instructions to store adjusted limits. For more information about permanently storing adjusted sett ings, refer to
“Default Settings.”
CAUTION:Alarm limits reset themselves to default values each time the
unit is powered up. Verify all alarm settings during system
startup to ensure that they are set as intended.
Reviewing, Setting, or Adjusting SpO2 and/or Pulse Alarm Limits
1.Ensure that the display unit is on.
2.Press the Alarm Limits button.
• Notice that the upper round LED is illuminated to the left of the Alarm
Limits button. This indicates the upper alarm limit, while the lower LED
indicates the lower alarm limit.
• Notice that the current setting appears in the %SpO
• Continue to press the Alarm Limits button until the alarm limit you want to
adjust is displayed.
• The Alarm Limits button can also be cycled to exit Set/Change mode, or
Set/Change mode will exit automatically after ten seconds with no activity.
3.Ensure that the appropriate upper or lower Alarm Limit LED is illuminated,
and that the alarm limit you want to change is displayed.
4.Press the Plus (+) or Minus (-) buttons to adjust the values as desired. Once
adjusted, Set/Change mode will exit automatically after ten seconds with no
activity, and the new limits will be active.
display.
2
Reviewing, Setting, or Adjusting Pulse and/or Alarm Volumes
1.Ensure that the display unit is on.
2.Press the Volume button once to change the alarm volume, or twice t o chan ge
the pulse volume.
• After pressing the Volume button once, notice that the Alarm Volume LED
appears, and the current settin g appears in the Pulse Rate display area.
• After pressing the Volume button twice, notice that the Pulse V olume LED
appears, and the current settin g appears in the Pulse Rate display area.
• The Volume button can also be cycled to exit Set/Change mode, or Set/
Change mode will exit automatically after ten seconds with no activity.
3.Use the Plus (+) or Minus (-) buttons to adjust the alarm or pulse volumes as
desired. Once adjusted, Set/Change mode will exit automatically after ten
seconds with no activity, and the new limits will be active.
28
Page 32
Error Codes
The Avant 4000 display unit includes error codes that indicate problems with the
unit. To correct error conditions, perform the following steps:
1.Turn the unit off and then back on again to remove the error code.
2.If the error persists, disconnect all power (AC and battery), and then
reconnect the power and turn the unit back on.
3.If the error still persists, note the error code and contact your distributor, or
contact Nonin Customer Support at (800) 356-8874 (USA and Canada) or
+1 (763) 553-9968.
29
Page 33
Communication
Communication
This chapter describes the memory, printing, and real-time capabilities of the Avant
4000 Digital Pulse Oximetry System.
Memory Features
The display unit can collect and store up to 33.5 hours of SpO2 and pulse rate
information.
®
Data may be played back with data retrieval software (NONIN’s nVISION
software is recommended). If you wish to create your own software, contact
NONIN for the data format.
NOTE: Only SpO
The memory in the system functions much like an “endless loop” tape. When the
memory fills up, the unit begins overwriting the oldest data with the new data.
Each time the system is turned on, the current time/date info rmation (if the clo ck
is set properly) is stored in memory, starting a new recording session. (See “Displays,
Indicators, and Controls” for more information about setting the clock.) Only
recording sessions greater than one minute in length are stored in memory.
Patient SpO
stored every 4 seconds. Ox ygen saturation value s are stored in 1% increm ents in the
range of 0 to 100%.
The stored pulse rate ranges from 18 to 300 pulses per minute. The stored values
are in increments of one pulse per minute in the interval from 18 to 200, and in
increments of two pulses per minute in the interval from 201 to 300.
WARNING: The battery pack must be installed at all times while the
and pulse rate are sampled every 2 seconds. The extreme value is
2
and pulse rate data are available for data retrieval.
2
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 NO T
use the device without batteries when patient safety relies
upon audible alarms.
30
Page 34
Playing Back Memory Data
The Avant 4000 Digital Pulse Oximetry System has a Memory Playback feature,
allowing stored data to be output through the RS232 serial connection.
1.With the display unit off, connect the RS-232 connector port of the display
unit to the back of your computer using a null modem cable.
2.With the display unit still off, press and hold the Memory button while
pressing the ON/STANDBY butt on.
• All LEDs will illuminate briefly . PLy bac will appear in the
and Pulse Rate LED display areas. This message signals that
SpO
2
the device is in Playback mode.
3.The PLy bAC message will disappear when memory playback is complete.
(Memory playback may take up to 8 minutes, depending upon the amount of
data.) Pressing the ON/STANDBY button will exit Playback mode.
4.A CLr no message will be displayed, and three informational tones will
sound.
5.(OPTIONAL): To clear the memory:
• Use the Plus or Minus buttons to select Clr YES.
• Press the ON/STANDBY button.
• To confirm the clearing of memory, use the Plus or Minus buttons
to select DEL YES.
• Press the ON/STANDBY button again.
• dnE CLr confirms that the memory is clear.
6.Press the ON/STANDBY button to return to normal operation.
31
Page 35
Communication
Real-Time Patient Data Output
The system provides real-time data output capability via the RS232 connector port.
A null modem cable must be connected from the display unit to the receiving
computer.
The information from the system in the real-time mode is sent in an ASCII serial
format at 9600 baud with 8 data bits, no parity, and 1 stop bit. The data are output
at a rate of once per second (on separate lines).
Real-time data may be printed or displayed b y devices other than t he pulse oximet er.
Upon power up, a header is sent identifying the format and the time and date.
Thereafter, the data are sent once per second by the system in one of the following
formats:
•If DIP switch 8 is in the DOWN position, the data will be displayed as follows:
SPO2=XXX HR=YYY
where XXX is the SpO
•If DIP switch 8 is in the UP position, the data will be displayed as follows:
where XXX and YYY are the fast-responding SpO
•If there are no data from the oximeter, the formats will appear as follows:
Nonin’s Avant 4000 Digital Pulse Oximetry System includes an event marker
feature. Events are indicated by a single “*” whenever ON /STANDBY is pressed
to enter Battery Capacity Display mode. (ON/STANDBY ma y be pressed again to
exit, or Battery Capacity Display m ode will time out after approx imately 10 seconds.)
This feature can be used to mark exceeded alarm limits, or in other situations as
desired.
value and YYY is the heart rate value.
2
SPO2=XXX HR=YYY F
2 and pulse rate values.
SPO2=--- HR=---
SPO2=XXX HR=YYY*
32
Page 36
Printing Options
The Avant 4000 Digital Pulse Oximetry System features printing capabilities
that allow printing on demand or in real-time. These printing options are controlled by DIP switch 4, which is found under the battery cover at the back of
the unit.
•When DIP switch 4 is in the UP position, real-time (once per second) data
output is available via the RS232 connector port, using a null modem cable.
•When DIP switch 4 is in the DOWN position (default), the Pr in t-on-Demand
mode is activated, allowing you to print only when desired.
To print displayed data on demand, press the ON/STANDBY button.
Important Notes
• Event markers are not available in Print-On-Demand mode.
• Print functions are available only with a 9600 baud serial ASCII printer.
• Printing features are not available during memory playback.
33
Page 37
Specifications
Specifications
MODEL 4100 WRIST-WORN PATIENT MODULE
Oxygen Saturation Range
(%SpO2)
Pulse Rate Range
Accuracy
Blood Oxygen Saturation
(%SpO2) (± 1 S.D.)
Pulse Rate
Displays
Connection Status LED
Measurement Wavelengths and Output Power
Red
Infrared
Internal Power
Battery
Operating Life
Storage Life
Weight
AVANT 4000 DISPLAY UNIT
Displays
Numeric Displays
Pulse Strength
Bargraph LED
Connection Status LED
Pulse Quality LED
Power Requirements
Mains
DC Input
Internal Power
Battery
Operating Life
Storage Life
Recharge
Dimensions
a
0% to 100%
18 to 300 pulses per minute
70-100% ±2 digits for adults using 8000AA-WO
Finger Clip Sensor
70-100% ±3 digits for adults using 8000J-WO Adult
Flex Sensor
Pole MountPole Mount
Avant PCPole Mount Clamp
Avant RSAvant Rolling Stand; available in standard or deluxe
Cord Set, Charger
Other Accessories
nVISION
4100WBReplacement Wrist Bands for A vant 4100 Patient Module
Avant CCCarrying case for Avant products
For more information about NONIN parts and accessories, contact your distributor,
or contact NONIN at (800) 356-8874 (USA and Canada) or +1 (763) 553-9968. This
information is also available on NONIN’s website: www.nonin.com.
®
nVISION® software for Microsoft Windows 95/98/2000/
NT 4.0 operating systems
(Pkg of 3)
36
Page 40
Service, Support, and Warranty
A return authorization number is required before returning any product to NONIN.
To obtain this return authorization number, contact NONIN Customer Support:
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
(800) 356-8874 (USA and Canada) +1 (763) 553-9968 (outside USA and Canada)
Fax +1 (763) 553-7807 E-mail: customersupport@nonin.com
www.nonin.com
Warranty
NONIN MEDICAL, INCORPORATED, (NONIN) warrants to the purchaser, for a
period of three years from the date of purchase, each display unit and wrist-worn patient
module. NONIN warrants the battery pack for the display unit for a period of one year
from the date of purchase.
NONIN shall repair or replace any Avant 40 00 Digital Pulse Ox imetry System found to be
defective in accordance with this warranty, free of charge, for which NONIN has been
notified by the purchaser by serial number that there is a defect, provided said notification
occurs within the applicable warranty period. This warranty shall be the sole and exclusive
remedy by the purchaser hereunder for any Avant 4000 Digital Pulse Oximetry System
delivered to the purchaser which is found to be defective in any manner, whether such
remedies be in contract, tort, or by law.
This warranty excludes cost of delivery to and from NONIN. All repaired units shall be
received by the purchaser at NONIN's place of business. NONIN reserves the right to
charge a fee for a warranty repair request on any A vant 4000 Digital Pulse Oximetry System
that is found to be within specifications.
This system is a precision electronic instrument and must be repaired by knowledgeable
and specially trained NONIN personnel only. Accordingly, any sign or evidence of opening
the devices, field service by non-NONIN personnel, tampering, or any kind of misuse or
abuse of the system, 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 tim e of de livery to
NONIN.
DISCLAIMER/EXCLUSIVITY OF WARRANTY:
THE EXPRESS W ARRANTIES 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.
37
Page 41
Tro ubles hooti ng
Troubleshooting
ProblemPossible CausePossible Solution
The display unit will
not activate.
The display unit will
not operate on
batteries.
You are unable to
obtain a green pulse
display on the
bargraph.
NOTE: In some
instances, patient perfusion
may be inadequate for pulse
detection.
The unit has no power.Plug in the AC adapter.
The battery pack is not
connected.
The battery pack is not
charged.
The battery pack is
inoperable.
The patient pulse
strength is low or
perfused poorly.
Circulation is reduced
because of excess
pressure on the sensor
(e.g., between the sensor
and a hard surface).
The digit is cold.Warm the digit by rubbing or
Check the battery pack
connection.
Plug in the AC Adapter to
charge the battery pack.
Contact your distributor or
NONIN Customer Support
for repair or replacement.
Reposition the digit or insert a
different digit, and keep the
sensor motionless for at least
10 seconds.
Warm the digit by rubbing or
covering with a blanket.
Position the sensor at a
different site.
Allow the hand to rest
comfortably without squeezing
or pressing the sensor on a
hard surface.
covering with a blanket.
38
The patient module is not
paired to the display.
Position the sensor at a
different site.
Make sure the patient module
is paired with the display.
Verify that the Connection
Status LED is green on both
the display unit and the patient
module.
Page 42
ProblemPossible CausePossible Solution
Unable to obtain a
green pulse display on
the bargraph, cont’d.
The sensor is applied
incorrectly.
There is possible
interference from one of
the following sources:
• arterial catheter
• blood pressure cuff
• electrosurgical
procedure
• infusion line
The red LED is not
illuminated in the finger
insertion area.
Apply the sensor correctly.
Reduce or eliminate any
interference. Make sure that
the sensor is not placed on the
same arm being used for other
patient therapies or diagnosti cs
(e.g., blood pressure cuff).
Ensure that the sensor is
securely attached to the 4100.
Check the 4100’s batteries.
Check the sensor for any
visible signs of deterioration.
Contact your distributor or
NONIN Customer Support.
Frequent or steady
pulse quality
indication.
There is excessive
ambient light.
The sensor is applied to a
polished or artificial
fingernail.
The red LED is not
illuminated in the finger
insertion area.
Patient motion is
excessive.
Shield the sensor from the
light source.
Apply the sensor to a finger
without artificial or polished
nails.
Position the sensor at a
different site.
Ensure that the sensor is
securely attached to the 4100.
Check the sensor for any
visible signs of deterioration.
Contact your distributor or
NONIN Customer Support.
Reduce patient motion.
39
Page 43
Tro ubles hooti ng
ProblemPossible CausePossible Solution
A dash (-) appears in
the %SpO
display.
2
A poor signal from the
digit is being detected.
Reposition the digit or insert a
different digit and keep the
sensor motionless for at least
10 seconds.
Position the sensor at a
different site.
An error code appears
in the display area.
The digit was removed
from the sensor.
The system is not
functioning.
The system encountered
an error.
Reinsert the digit and keep the
sensor motionless for at least
10 seconds.
Turn off the unit, check all
connections, and retry.
Verify that the 4100 is paired
with the display.
Verify that the Connection
Status LED is green on both
the display unit and the patient
module.
Contact your distributor or
NONIN Customer Support.
1. Turn the unit off and then
back on again to remove
the error code.
2. If the error persists,
disconnect all power (AC
and battery), and then
reconnect the power and
turn the unit back on.
3. If the error still persists,
note the error code and
contact your distributor or
NONIN Customer
Support.
40
Page 44
ProblemPossible CausePossible Solution
The unit is in Alarm
mode, but no audible
alarms can be heard.
The devices will not
pair.
The 2-minute Alarm
Silence button is
activated.
DIP switch 2 is in the UP
position, and the unit’s
volume is set to zero.
The system is not
functioning correctly.
The sensor has not been
disconnected and
reconnected.
The patient module is out
of range.
The Bluetooth Control
button was not pressed
and held while turning on
the display unit.
Press the Alarm Silence button
to re-engage alarm volume, or
wait for two minutes—and
alarm tones will automatically
re-engage.
Adjust the alarm volume, or
return DIP switch 2 to the
DOWN position if you desire
audible alarms.
Contact your distributor or
NONIN Customer Support.
Disconnect and reconnect the
sensor to the 4100.
Ensure that the patient module
is in range while being paired
(approximately 30 feet—
spherical radius).
Starting with the display unit
turned off, press and hold the
Bluetooth Control button
while turning on the display
unit. (See “Device Pairing” for
more information.)
If these solutions do not correct the problem, please contact your distributor, or
contact NONIN Customer Support at (800) 356-8874 (USA and Canada) or
+1 (763) 553-9968.
41
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