Operator’s Manual
®
Avant 4100
Avant® 4000 Digital
Pulse Oximetry System
with Bluetooth
Wireless Technology
®
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 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.
© 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
S
S
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
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
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
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
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
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Group 2 This device must emit electromagnetic
Class B This 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
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
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
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
Installing Batteries in the Patient Module
9
Using the Avant™ 4000 Digital Pulse Oximetry System
1
3
14 15
13
12
16 17
™
20
18
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
4
5
6
21
22 23
2
7
19
25
24
8
9
10
11
26
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
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.
11
Loading...