Operator’s Manual
0
™
Avant 212
Pulse Oximeter
and NIBP Monitor
0123
English
1
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 2120 Pulse Oximeter and Noninvasive Blood
Pressure Monitor.
The information in this manual has been checked carefully and is believed to be
accurate. In the interest of continued product development, NONIN reserves the
right to make changes and improvements to this manual and the products it
describes at any time, without notice or obligation.
Nonin Medical, Inc.
2605 Fernbrook Lane North
Plymouth, Minnesota 55447-4755
USA
• (763) 553-9968
• (800) 356-8874 (USA and Canada)
• Fax (763) 553-7807
• mail@nonin.com
• www.nonin.com
References to “NONIN” in this manual shall imply Nonin Medical, Inc.
Nonin is a registered trademark of Nonin Medical, Inc.
© 2003 Nonin Medical, Inc.
Authorized EC Representative:
MPS Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
Guide to Symbols ........................................................ 1
Precautions for Use ....................................................2
Using the Avant 2120 .................................................. 5
Indications for Use ......................................................... 5
Installing the Batteries .................................................... 6
Verifying Avant 2120 Operation ..................................7
Avant 2120 Alarm Limit Power On Defaults ............7
Displays, Indicators, and Controls ...............................8
Taking %SpO2 Measurements ...................................13
Taking Blood Pressure Measurements ......................13
Automatic and Demand NIBP Measurements ........16
Calibrating Blood Pressure on the Avant 2120 ........ 17
Advanced Features ........................................................18
Printing Quick Reference ............................................20
Care and Maintenance ..................................................21
Alarms and Limits .................................................... 22
Alarms ............................................................................. 22
Alarm Summary ............................................................. 24
Setting and Changing Volume and Alarm Limits ....25
Setting and Changing NIBP Settings .........................26
Communication ........................................................ 27
Memory Features ..........................................................27
Using the Avant 2120 with nVISION™ Software ..28
Real-Time Patient Data Output .................................. 29
Specifications ............................................................ 30
Parts and Accessories ............................................... 32
Service, Support, and Warranty ................................ 34
Troubleshooting ....................................................... 36
Guide to Symbols
S
S
Detailed information about functional symbols can be found in this manual’s “Using
the Avant 2120” section.
Symbol Description/Function
Attention: See Instructions for Use or related materials.
!
Type BF Applied Part: Defibrillator Proof (Patient
isolation from electrical shock). Applies to NIBP.
Type BF Applied Part
(Patient isolation from electrical shock). Applies to pulse
oximeter.
I
S
F
I
E
A
D
L
C
U
C
L
UL Mark for Canada and the United States with respect to
electric shock, fire, and mechanical hazards only in accordance
U
with UL 2601-1 and CAN/CSA C22.1 No. 601.1.
0123
SN
CE Marking indicating conformance to EC directive No.
93/42/EEC concerning medical devices.
Serial Number (located under the battery cover).
Signal Output
1
Precautions for Use
Precautions for Use
Read and follow all safety instructions in this chapter before using the Avant 2120.
Contraindications
Do not use the Avant 2120 in a magnetic resonance imaging (MRI) environment.
Do not use the blood pressure module of the Avant 2120 on neonatal patients.
Warnings
The Avant 2120 is intended only as an adjunct in patient assessment. It must be used in
conjunction with other methods of assessing clinical signs and symptoms.
This equipment is intended for use in the presence of electrosurgery; however, its general operation might be affected by the use of an electrosurgical unit (ESU).
As with all medical equipment, carefully route patient cables and connections to reduce
the possibility of patient entanglement or strangulation.
Use the Avant 2120 only within the specified temperature ranges: +32°F to +122°F
(0°C to 50°C) for operating, and -22°F to 122°F (-30°C to +50°C) for storage and
transportation.
Do not use a damaged sensor or NIBP cuff under any circumstances.
All parts and accessories connected to the serial port of the Avant 2120 must be certified according to IEC Standard EN 60950 or UL 1950 for data-processing equipment.
Use the Avant 2120 with 300PS-XX, where XX represents the power supply designation.
The Avant 2120 NIBP function has been designed for use on patients with normal sinus
rhythms.
Use only NONIN-manufactured pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for NONIN pulse oximeters. Using other
manufacturers’ sensors can result in improper pulse oximeter performance.
Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the
adhesive material.
Explosion Hazard: Do not use the Avant 2120 in an explosive atmosphere or in the
presence of flammable anesthetics or gases.
Do not stretch the adhesive tape while applying the pulse oximeter sensor.
Applying the blood pressure cuff to the same arm used for a pulse oximeter might affect
pulse oximeter readings.
Use only NONIN-supplied blood pressure cuffs and hoses. Using other cuffs might
result in inaccurate readings or inability to operate the Avant 2120.
Do not compress or hold the blood pressure cuff or cuff hose while the Avant 2120 is
operating.
Do not apply the blood pressure cuff to an arm being used for intravenous infusion or
to any area with restricted circulation.
Do not use the blood pressure cuff on neonates and patients known to be readily susceptible to bruising.
Ensure that the blood pressure cuff is sized and placed correctly for each patient.
2
Ensure that all Avant 2120 users know how to manually remove the blood pressure cuff
in case it fails to deflate.
The safety and effectiveness of the Avant 2120 NIBP function in pregnant women have
not been established.
Do not operate the Avant 2120 blood pressure module unless it has been properly calibrated. Inaccurate blood pressure readings can result if the Avant 2120 has not been
calibrated properly. A calibration check is recommended at least once every year.
Cautions
Before using any sensor or NIBP cuff, carefully read the Directions for Use, which contain specific application times.
Do not, under any circumstances, perform any testing or maintenance on the Avant
2120 while it is being used to monitor a patient.
This equipment complies with International Standard EN 60601-1-2:1993 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 (for example, cellular phones, mobile two-way radios, electrical appliances), 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.
Verify that all visible indicators light during the start- up (initialization) sequence. If any
indicator does not illuminate (except the AC Power Adapter LED), do not use the
Avant 2120. Contact NONIN Customer Support for assistance.
If the Avant 2120 fails to respond as described, discontinue use until the situation has
been corrected by qualified personnel.
Do not remove any covers other than the battery cover when replacing batteries. There
are no user-serviceable parts inside—other than the replaceable batteries.
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.
Do not immerse the Avant 2120 or NONIN sensors in water or any other liquids, and
do not place liquids on top of the Avant 2120.
The Avant 2120 is a precision electronic instrument. It must be repaired by trained
NONIN personnel only.
The Avant 2120 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 Avant 2120 might misinterpret motion as good pulse quality (as indicated by a
green pulse quality display). Minimize the patient’s finger motion as much as possible,
or change the type of sensor being used (e.g., ear clip).
3
Precautions for Use
Check the pulse oximeter sensor application site frequently to determine the positioning
of the sensor and the circulation and skin sensitivity of the patient. Patient sensitivity to
the Avant 2120 varies depending on medical status or skin condition.
Do not use the 300PS-UNIV battery charger if the integrity of the protective earth conductor of the AC cord or the outlet is in doubt.
Cardiogreen and other intravascular dyes, depending upon their concentrations, might
affect the accuracy of the SpO
Ear Clip and Reflectance sensors are not recommended for pediatric use. The accuracy
of the sensors has not been established for pediatric use.
Some nail polish colors or artificial nails can reduce light transmission and affect SpO2
accuracy.
Check the NIBP cuff application site frequently to ensure that the cuff is not causing
prolonged impairment of the patient’s circulation.
The Avant 2120 might not work on all patients. Check to ensure that the proper cuff
size is used. If you are unable to achieve stable readings, discontinue use.
In certain circumstances, the normal application of a blood pressure cuff might exasperate an underlying medical condition. Be aware of potential circulatory disorders in all
patients using the Avant 2120.
Blood pressure recordings can be affected by the subject’s position, physiological condition, and other factors.
When using the 300PS-UNIV battery charger, ensure that the AC cord is plugged into a
grounded outlet.
measurement.
2
4
Using the Avant 2120
This section describes how to use the Avant 2120.
Indications for Use
The NONIN® Avant 2120 Pulse Oximeter and NIBP Monitor is a portable device
indicated for use in measuring and displaying functional oxygen saturation of arterial
hemoglobin (SpO
hospitals, medical facilities, and subacute environments. The Avant 2120 is intended
for spot-checking and/or continuous monitoring of patients. Its functions may be
used separately or simultaneously.
Pulse Oximeter Intended Use
The pulse oximeter is intended for noninvasively monitoring the oxygen saturation
and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical
facilities, and subacute environments. It may be used for spot-checking and/or
continuous monitoring of patients.
Blood Pressure Monitor Intended Use
The blood pressure monitor is intended for noninvasively monitoring the blood
pressure of adult and pediatric patients in hospitals, medical facilities, and subacute
environments. The blood pressure monitor is not intended for use with neonates. It is intended
for attended care and may be used for spot-checking. The Avant 2120 should be
used for patients with arm circumferences of 18-42 cm.
), pulse rate, and blood pressure of adult and pediatric patients in
2
MAP
mmHg
5
Using the Avant 2120
Installing the Batteries
2120.003
NOTE: Reposition the back cover carefully, and tighten the screws
firmly—being careful not to over-tighten. Contact NONIN to
purchase or replace battery packs.
NOTE: Removing power from the Avant 2120 erases all previous oximetry
and NIBP data, but it does not erase any user-defined alarm
limits.
6
Verifying Avant 2120 Operation
Press the ON/STANDBY button. When the unit is first turned on, the Avant 2120
performs a brief startup (initialization) sequence. Verify that all LEDs illuminate and
the unit beeps three times during the first phase of the startup sequence. If any LED
is not lit (except the AC Power Adapter LED), do not use the Avant 2120. Contact
NONIN Customer Support for assistance.
In order to verify that the Avant 2120 is functioning properly, it is important to
monitor SpO
the pulse oximeter sensor is functioning properly.
1. Ensure that the Avant 2120 is on, with the sensor connected.
2. Apply the pulse oximeter sensor.
3. Verify that a good SpO2 reading is displayed, that a pulse rate value appears,
and that the pulse strength bargraph LED is active.
and pulse rate readings. Use the following procedure to verify that
2
Avant 2120 Alarm Limit Power On Defaults
The Avant 2120 provides the capability to define power on alarm limit defaults that
are different than the factory settings. The two sets of defaults are selected using
DIP switch 8 (DOWN = Factory, UP = User Defined).
During initialization, FAC DFL or USR DFL will appear briefly in the SpO
and Pulse Rate display areas to indicate which set of defaults are in use. After
initialization, any of the alarm limits can be modified.
To program user-defined power on alarm limit defaults, set DIP switch 8 to the UP
position. A value for each limit must be programmed before the unit will continue
to operate.
To return to factory power on defaults, DIP switch 8 must be set in the DOWN
position before entering power on initialization.
NOTE: The unit must be using factory defaults before programming user-
defined power on alarm limit defaults.
2
7
Using the Avant 2120
Displays, Indicators, and Controls
This section describes the Avant 2120’s displays, indicators, and controls.
Avant 2120 Parameter Displays
%SpO
Display
2
Numeric light-emitting diodes (LEDs) on the upper left-hand corner of the Avant 2120
display blood oxygen saturation in percent.
Pulse Rate Display
The pulse rate display is the lower numeric display on the upper left-hand corner of the
Avant 2120 (identified by the symbol). This 3-digit LED display shows the pulse
rate in beats per minute.
Systolic Pressure Display
The systolic display is a 3-digit LED display near the upper right-hand corner of the
Avant 2120. The Systolic number displayed represents the blood pressure in mmHg
during contraction of the ventricles.
Diastolic Pressure Display
The diastolic display is a 3-digit LED display in the middle right-hand side of the
Avant 2120. The Diastolic number displayed represents the blood pressure in
mmHg when the ventricles are relaxed.
MAP (Mean Arterial Pressure) Display
The MAP display is a 3-digit LED display near the middle right-hand side of the
Avant 2120. The MAP number displayed is a calculated value in mmHg, based on
measurements of systolic and diastolic pressure:
MAP = 2/3 diastolic + 1/3 systolic
Numeric LEDs
Numeric LEDs appear for SpO2, Pulse Rate, and blood pressure data, and
for time and date displays, cuff pressure, volume, and NIBP history review.
There are five 3-digit multicolor numeric LEDs on the Avant 2120. They
are used for SpO
conditions, these LEDs are displayed in green. For high priority (patient)
alarms, the values are displayed in red, blinking fast. For medium priority
(equipment) alarms, the values are displayed in amber, blinking slowly.
There is a four-digit, green, numeric LED on the Avant 2120 as well. It is
used primarily to display date and time information, adjust volumes, adjust
the auto NIBP cycle time, and set the initial NIBP cuff pressure.
pulse rate, and blood pressure displays. Under normal
2,
8
Indicators and Icons
Pulse Oximeter Sensor LED
The Pulse Oximeter Sensor LED indicates when a sensor has become
disconnected, has failed, or has not been applied correctly.
Pulse Strength Bargraph LED
This 10-segment multicolor bargraph indicates pulse strength as
determined by the oximeter. The bargraph changes color based upon
the strength of the pulse. The color and height of the Pulse Strength
Bargraph is proportional to the pulse amplitude. For a low pulse
amplitude, the unit goes into High Priority Alarm mode.
Green = a good pulse strength
Amber = a marginal pulse strength
Red = a low pulse strength, high priority alarm
The Pulse Strength Bargraph LED also indicates the battery charge
percentage in 10% increments in green, displaying the depleted
portion of the bargraph in amber.
Pulse Quality LED
This LED blinks to indicate a poor pulse quality. If there is a sustained
series of poor pulses, the Pulse LED will illuminate solid.
Pulse Volume LED
This amber LED indicates that the unit is in Pulse Volume Program
mode. When this LED is lit, pulse volume can be adjusted using the
Plus (+) and Minus (-) buttons on the front panel. The highest volume
is 15, and the lowest volume is 0. The default volume level is 4. The
Avant 2120 beeps while pulse volume is being changed, showing the
volume progression as it is adjusted.
Auto NIBP Mode LED
This multicolor LED indicates that the unit is in Auto NIBP mode
when it is lit green. When lit amber, this LED indicates that the unit is
in Auto NIBP Cycle Time Program mode. The cycle time can be
adjusted using the Plus (+) and Minus (-) buttons.
Keypad Round LED Indicators
Keypad round LED indicators display whether or not the Avant 2120
is functioning in certain modes (NIBP History Display mode or Initial
mmHg
Cuff Pressure Display/Modify mode).
9
Using the Avant 2120
Battery LED
This amber LED indicates a marginal battery capacity by blinking in
sync with the Main Alarm LED indicator. In addition, this LED—
when lit solid—indicates that the battery capacity is being displayed.
This LED does not indicate that the Avant 2120 is running on battery power.
AC Power Adapter LED
This green LED is displayed when an external power supply is
providing power to the Avant 2120.
Alarm Silence LED
This amber LED indicates that the audible alarm is temporarily
silenced when it blinks. When lit solid, the Alarm Silence LED
indicates that the audible alarm volume is set to zero.
Main Alarm LED
The Main Alarm LED indicates visible alarm conditions. It indicates
high priority (via red color blinking fast) or medium priority (via amber
color blinking slowly) alarm conditions.
Alarm Volume LED
This amber LED indicates that the unit is in Alarm Volume Program
mode. When this button is illuminated, the alarm volume can be
adjusted by using the Plus (+) and Minus (-) buttons on the front panel.
The highest volume is 15, and lowest volume is 8. The default volume
level is 8. If DIP switch 2 is moved to the UP position, then the alarm
volume can be adjusted to zero.
10
Time, Month, Day, and Year LEDs
These amber LEDs indicate that the Avant 2120’s Time, Month, Day, or
Ye ar displays can be reviewed or adjusted using the Plus (+) and Minus
(-) buttons.
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