Nonin 2120 User manual

Operator’s Manual
Pulse Oximeter
and NIBP Monitor
 
Avant 2120
™

0123
English

NONIN®reserves the right to make changes and improvements to this
manual and the products it describes at any time, without notice or
obligation.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443
USA
[phone]
[phone] (USA and Canada)
Fax [phone]
[e-mail]
www.nonin.com
Authorized EC Representative:
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
References to “NONIN” in this manual imply Nonin Medical, Inc.
NONIN, Flexi-Form, FlexiWrap, PureLight and nVISION are registered
trademarks or trademarks of Nonin Medical, Inc. Microsoft® and Windows® are
registered trademarks of Microsoft Corporation.
© 2007 NONIN Medical, Inc.
6141-001-01
CAUTION: Federal law (USA) restricts this device to sale by or
on the order of a licensed practitioner.
Consult Instructions for Use.
EC
REP

i
Contents
Guide to Symbols ...............................................................1
Indications for Use .............................................................2
Contraindications ......................................................................2
Warnings ...................................................................................2
Cautions ....................................................................................5
Displays, Indicators, and Controls ...................................8
Parameter Displays ...................................................................8
Indicators and Icons ..................................................................9
Display Panel Buttons .............................................................12
Operating the Device .......................................................15
Installing the Batteries .............................................................15
Verifying Operation .................................................................16
Alarm Limit Defaults ................................................................16
NIBP and %SpO2 Functions ...................................................17
Operator Functions ..........................................................18
Taking Blood Pressure Measurements ...................................18
Automatic and Demand NIBP Measurements ........................22
Calibrating Blood Pressure .....................................................23
Advanced Features ..........................................................24
Button Combinations ...............................................................24
DIP Switches ...........................................................................25
Quick Reference for Printing ...................................................26
Communication ................................................................27
Memory Features ....................................................................27
Using nVISION Data Management Software ..........................28
Real-Time Patient Data Output ...............................................29
Care and Maintenance .....................................................30
Cleaning ..................................................................................30
Cleaning the Blood Pressure Cuff ...........................................30
Alarms and Limits ............................................................31
Alarms .....................................................................................31
Alarm Summary ......................................................................34
Setting and Changing Volume and Alarm Limits .....................35
Setting and Changing NIBP Settings ......................................37
Parts and Accessories .....................................................38
Service, Support and Warranty .......................................40
Warranty ..................................................................................41
Troubleshooting ...............................................................42
1

ii
Technical Information ......................................................46
Manufacturer’s Declaration .....................................................46
Equipment Response Time .....................................................50
Testing Summary ....................................................................51
NIBP Testing Summary ...........................................................52
Specifications ..........................................................................53
1

1
Guide to Symbols
This Table describes the symbols that are found on the Avant Model
2120. See Section titled Displays, Indicator, and Controls for detailed
information about functional symbols.
Symbol Description/Function
Consult Instructions for Use
Defibrillation-Proof Type BF Applied Part (Patient
isolation from electrical shock). Applies to NIBP.
Type BF Applied Part (Patient isolation from electrical
shock). Applies to pulse oximeter.
UL Mark for Canada and the United States with
respect to electric shock, fire, and mechanical
hazards only in accordance with UL 60601-1 and
CAN/CSA C22.2 No. 601.1.
CE Marking indicating conformance to EC directive
No. 93/42/EEC concerning medical devices.
Serial Number
Indicates separate collection for electrical and
electronic equipment (WEEE).
IPX2 Protected against vertically falling water drops when
enclosure is tilted up to 15 degrees, per IEC 60529.
%SPO2%SpO2 Display
Pulse Rate Display
Signal Output
C
L
A
S
S
I
F
I
E
D
US
CUL
0123
SN

2
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 (SpO2), pulse rate, and blood pressure
ofadultandpediatricpatientsinhospitals,medicalfacilities,andsubacute
environments. The Avant 2120 is intended for spot-checking and/or
continuous monitoring of patients during both motion and no-motion
conditions, for patients who are well or poorly perfused. Its functions may
be used separately or simultaneously.
The blood pressure monitor is intended for noninvasive monitoring of the
blood pressure of adult and pediatric patients in hospitals, medical
facilities, and subacuteenvironments. It isintendedfor attended careand
may be used for spot-checking. The device should be used for patients
with arm circumferences of 18-42 cm.
Contraindications
Do not use this device in an MR environment.
Do not use this device in an explosive atmosphere.
The pulse oximeter portion of this device is not defibrillation proof per
IEC 60601-1:1990 clause 17h.
The blood pressure monitor is not intended for use with neonates.
Warnings
This device is intended only as an adjunct device in patient
assessment. It must be used in conjunction with other methods of
assessing clinical signs and symptoms.
This device must be able to measure the pulse properly to obtain an
accurate SpO2measurement. Verify that nothing is hindering the
pulse measurement before relying on the SpO2measurement.
Operation of this device below the minimum amplitude of 0.3%
modulation may cause inaccurate results.

3
General operation of this device may be affected by the use of an
electrosurgical unit (ESU).
The use of accessories other than those specified in these
instructions may result in increased electromagnetic emission and/or
decreased immunity of this device.
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.
Do not use a damaged sensor.
As with all medical equipment, carefully route patient cables and
connections to reduce the possibility of entanglement or
strangulation.
This device turns off after approximately 30 minutes when in low
battery mode.
The battery pack must be installed at all times while the device is
operating, even when operating on AC power. The audible alarms
and memory will not function if batteries are removed from the device.
Do not use the device without batteries.
Use this device only with Power Adapters supplied by NONIN
Medical.
Warnings (Continued)

4
Do not use this device in or around water or any other liquid, with or
without AC power.
To comply with relevant product safety standards, ensure that all
alarm volumes are set appropriately and are audible in all situations.
Do not cover or otherwise hinder any speaker openings.
This device is a precision electronic instrument and must be repaired
by qualified technical professionals. Field repair of the device is not
possible. Do not attempt to open the case or repair the electronics.
Opening the case may damage the device and void the warranty.
To obtain accurate results, and for important safety reasons, the
blood pressure cuff must only be placed on the patient’s arm.
Use only NONIN-specified blood pressure cuffs and hoses with the
device. Using other cuffs might result in inaccurate readings or
inability to operate the device.
Use only NONIN-branded PureLight pulse oximeter sensors. These
sensors are manufactured to meet the accuracy specifications for
NONIN pulse oximeters.
Warnings (Continued)

5
Cautions
This equipment complies with IEC 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 device fails to respond as described, discontinue use until the
situation is corrected by qualified technical professionals.
Do not autoclave or immerse this device in liquid or use caustic or
abrasive cleaning agents.
Batteries may leak or explode if used or disposed of improperly.
In some circumstances, the device may interpret motion as good
pulse quality. Minimize patient motion as much as possible.
Inspect the sensor application site at least every 6 to 8 hours to
ensure correct sensor alignment and skin integrity. Patient sensitivity
to sensors and/or double-backed adhesive strips may vary due to
medical status or skin condition.
Do not place liquids on top of this device.
Do not immerse this device or sensors in any liquids.
!

6
Follow local, state and national governing ordinances and recycling
instructions regarding disposal or recycling of the device and device
components, including batteries.
When using the 300PS-UNIV battery charger, ensure that the AC
cord is plugged into a grounded outlet.
To prevent potential loss of monitoring, do not use ear clip or
reflective sensors on pediatric or neonatal patients.
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.
Data is overwritten ONE RECORD AT A TIME so if the entire memory is filled with a single record, portions of that record will be deleted
when a new record begins.
A functional tester cannot be used to assess the accuracy of a pulse
oximeter monitor or sensor.
All parts and accessories connected to the serial port of this device
must be certified according to at least IEC 60950 or UL 1950 for data-
processing equipment.
Cautions (Continued)
!

7
This device is designed to determine the percentage of arterial
oxygen saturation of functional hemoglobin. Factors that may
degrade pulse oximeter performance or affect the accuracy of the
measurement include the following:
- excessive ambient light
- excessive motion
- electrosurgical interference
- blood flow restrictors (arterial catheters, blood pressure cuffs,
infusion lines)
- moisture in the sensor
- improperly applied sensor
- incorrect sonsor type
- poor pulse quality
- venous pusations
- anemia or low hemoglobin concentrations
- cardiogreen and other intravascular dyes
- carboxyhemoglobin
- methemoglobin
- dysfunctional hemoglobin
- artificial nails or fingernail polish.
The device may not work when circulation is reduced. Warm or rub
the finger, or ensure proper positioning of tubing/device.
This device’s display will go blank after 30 seconds of no readings or
poor readings.
Do not place DIP switch 1 in the UP position unless device calibration
is intended.
Cautions (Continued)
!

8
Displays, Indicators, and Controls
This section describes the displays, indicators, and controls used on the
Avant 2120.
Parameter Displays
%SpO2Display
Numeric light-emitting diodes (LEDs) on the upper left-hand corner of the
device display blood oxygen saturation in percent.
Pulse Rate Display
The pulse rate display is the lower numericdisplay on the upper left-hand
corner of the device (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 device. The Systolic number displayed represents theblood
pressure in mmHg during contraction of the ventricles.
Diastolic Pressure Display
The diastolic display is a 3-digit LED displayin the middleright-hand side
of the device. The Diastolic number displayed represents the blood
pressure in mmHg when the ventricles are relaxed.
MAP
mmHg

9
MAP (Mean Arterial Pressure) Display
The MAP display is a 3-digit LED display near the middle right-hand side
of the device. The MAP number displayedis a calculated valuein mmHg,
based on measurements of systolic and diastolic pressure:
MAP = 2/3 diastolic + 1/3 systolic
NOTE: LED means “light-emitting diode.”
Indicators and Icons
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 multi color numeric LEDs on the device.
They are used for SpO2, pulse rate, and blood pressure
displays.
• Green numeric LEDs display %SpO2 and pulse rate
values. When setting the device, the LEDs also display
values for alarm limits, volume, and date and time
settings.
• Amber slowly blinking LEDs indicate a medium priority
(equipment) alarm.
• Red, rapidly blinking LEDs indicate a High Priority
patient alarm.
There is also a four-digit, green, numeric LED on the device. 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 Oximeter Sensor LED
The Pulse Oximeter Sensor LED indicates when a sensor
has becomedisconnected,has failed, is misplaced oris not
compatible with this monitor.

10
Pulse Strength / Battery Capacity Bar Graph
LED
This 10-segment multi color bar graph indicates pulse
strength as determined by the oximeter. The bar graph
changes color based upon the strength of the pulse. The
color and height of the Pulse Strength Bar Graph is
proportional to the pulse amplitude. For a low pulse
amplitude, the device goes into High Priority Alarm mode.
Green = a good pulse strength
Amber = a marginal pulse strength
Red = a non-discernible pulse strength, high priority alarm.
The Pulse Strength / Battery Capacity Bar Graph LED
indicates the battery capacity in 10% increments. Amber
represents the depleted capacity of the battery and green
indicates the available battery capacity.
Pulse Quality LED
This LED blinks to indicate an inadequate pulse quality. If
there is a sustained series of inadequate pulses, the Pulse
LED will illuminate solid.
Pulse Volume LED
This amber LED indicates that the device 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 device
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 device is in Auto
NIBP mode when it is lit green. When lit amber, this LED
indicates that the device is in Auto NIBP Cycle Time
Program mode. The cycle time can be adjusted using the
Plus (+) and Minus (-) buttons.
Display Panel LED Indicators
Display panel LED indicators display whether or not the
Avant 2120 is functioning in certain modes (NIBP History
Display mode or Initial Cuff Pressure Display mode).
mmHg

11
Battery LED
This amber LED indicates a marginal battery capacity by
blinking in sync with the Main Alarm LED indicator. 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.
WARNING: The battery pack must be installed at all times while
the device is operating, even when operating on AC power. The
audible alarms and memory will not function if batteries are
removed from the device. Do NOT use the device without
batteries.
AC Power Adapter LED
This green LED is displayed when an external power
supply is providing power to the device.
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. A
rapid blinking red main alarm LED indicates high priority;
medium priority alarm condition is indicated by a slowly
blinking amber main alarm LED.
Alarm Volume LED
This amber LED indicates that the device is in Alarm
Volume Program mode. When this button is illuminated,
the alarmvolume 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.
Time, Month, Day, and Year LEDs
These amber LEDs indicate that the Time, Month, Day, or
Year displays can be reviewed or adjusted using the Plus
(+) and Minus (-) buttons.

12
Display Panel Buttons
NIBP Button
This button is used to begin or cancel a single blood
pressure measurement. While the device is taking a blood
pressure reading, pressing any button on the front panel
will cancel the action and deflate the cuff.
Auto NIBP Cycle Time Button
This button is used to display the automatic blood pressure
measurement cycle time. The Plus (+) and Minus (-)
buttons are used to change the cycle time setting. The
device can be set to start a blood pressure reading every
1, 2, 3, 5, 10, 15, 30, 45, 60, or 90 minutes after the
previous blood pressure reading is complete. The NIBP
timer begins after the previous blood pressure
measurement is completed.
NIBP History Review Button
This button displays previously measured blood pressure
values. The Plus (+) and Minus (-) buttons can be used to
scroll through and display stored NIBP readings. By using
the NIBP History Review Button, the last 300 readings
may be reviewed. Readings are not lost when the device is
in Standby mode. Readings from previous sessions are
indicated with a blinking time stamp.
Initial Cuff Pressure Button
This button displays the initial cuff inflation pressure (i.e.,
the amount of pressure to which the cuff initially inflates)
when obtaining a reading. The inflation pressure will
readjust, based on the patient’s previous blood pressure.
The initial cuff pressure can be changed using the Plus (+)
and Minus (-) buttons. Initial cuff pressure can be set to
120, 140, 160, 180, 200, 220, or 240 mmHg.
mmHg

13
ON/STANDBY Button
This button toggles the device between ON and
STANDBY modes. Pressing this button once turns on the
device. Pressing and holding this button for at least 1
second turns off the device.
Briefly pressing this button while the device is on displays
the battery capacity, in 10% increments. Amber represents
the depleted capacity of the battery and green indicates
the available capacity. If the ON/STANDBY button is
pressed again, the battery capacity display exits. The
battery capacity display will exit automatically after four
seconds.
Alarm Silence Button
This button toggles the alarm between silenced and
audible. Pressing the Alarm Silence button silences all
alarms for two minutes. Pressing and holding this button
for two seconds clears all NIBP high and medium priority
alarms (including any displayed NIBP data).
Limits Button
This button displays the upper and lower limits for alarm
indications for SpO2, heart rate, systolic, diastolic, and
MAP measurements. These limits can be adjusted using
the Plus (+) and Minus (-) buttons. The upper LED
indicates the upper alarm limit is being displayed, and the
lower LED indicates the lower alarm limit is being
displayed. The limit values are displayed in amber.
Plus and Minus Buttons
The Plus and Minus buttons are used to adjust timing of
automatic blood pressure readings, initial cuff pressure,
time, date, volume, upper and lower alarm limits, and they
are used to scroll through the NIBP history. Pressing this
button, when the device is not in program mode, adjusts
the intensity of the LED displays.

14
Time/Date Button
This button displays the time and date. Pressing the button
allows the user to set the year, month, day, hour, and
minute, with the Plus (+) and Minus (-) buttons. In US
mode, pressing the button allows the user to set the year,
month, day, hour, and minute with the Plus (+) and Minus
(-) buttons. Placing DIP switch 3 in the UP position allows
users to view and set the time and date in International
mode.
Volume Button
This button displays the pulse volume and alarm volume,
identified by the illuminated LED. The pulse and alarm
volumes can be adjusted using the Plus (+) and Minus (-)
buttons.

15
Operating the Device
I
Installing the Batteries
• Remove the back cover by loosening the screws.
• Insert the battery pack as illustrated.
• Reposition the back cover carefully and tighten the screws firmly, do
not over-tighten.
• Removing batteries from the device deletes all previous oximetry and
NIBP data; it does not delete user-defined alarm limits.
WARNING: The battery pack must be installed at all times while the
device is operating, even when operating on AC power. The
audible alarms and memory will not function if batteries are
removed from the device. Do NOT use the device without
batteries.
2120.003

16
Verifying Operation
Press the ON/STANDBY button to perform the start-up (initialization)
sequence. Verify that all LEDs, except the AC Power Adapter LED, are
illuminated and the unit beeps three times during the start-up sequence.
If any LED is not lit, do not use the device and contact NONIN Technical
Service for assistance.
Use the following procedure to verify that the pulse oximeter sensor is
functioning properly.
1. Ensure the device is on and the sensor is connected to the monitor.
2. Apply the pulse oximeter sensor to the patient.
3. Verify SpO2and pulse rate values are displayed, and the pulse
strength bar graph LED is activated.
Alarm Limit Defaults
During initialization, FAC DFL or USR DFL will appear briefly in the
SpO2and Pulse Rate displays to indicate which defaults are in use; after
initialization, any of the defaults can be modified.
To program user-defined alarm limit and volume defaults, set DIP
switch 8 to the UP position. A value for each limit must be programmed
before the device will continue to operate.
To return to factory defaults, DIP switch 8 must be set in the DOWN
position before entering start-up initialization.
NOTE: The device must be in factory default mode before programming
user-defined alarm limit and volume defaults.