Nonin 2120 User manual

Operator’s Manual
PulseOximeter
andNIBPMonitor
 
Model 212
0
1
012
3
English
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Declaration of Conformity
Manufacturer: Nonin Medical, Inc.
Address: 2605 Fernbrook Lane North
Plymouth, Minnesota 55447-4755
USA
Model Number: 2120
We herewith declare that the above-mentioned pulse oximeter and blood pressure
monitor are classified as Class IIb (using Rule 10)and comply with EC Directive
No. 93/42/EEC concerning medical devices for all devices manufactured after
July 1, 2001.
This declaration is based on:
Certification of a Quality System to ISO 9001 : 1994 / EN 46001 : 1996
Certificate Number: Q1 98 12 24497 005
Issued by: TUV Product Service GmbH
Date: December 1998
Certification according to Annex II, Clause 3 of EC Directive No. 93/42/
EEC concerning medical devices.
Certificate Number: G1 98 12 24497 004
Issued by: TUV Product Service GmbH
Date: December 1998
Place: Nonin Medical, Inc.
Plymouth Minnesota
Date: 01 July 2001
Signature:
Name: Jerry Zweigbaum
Title: CEO
Authorized EC Representative:
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
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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
Model 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
•[phone]
•[phone] (USA and Canada)
•Fax [phone]
•[e-mail]
•www.nonin.com
References to “NONIN” in this manual shall imply Nonin Medical, Inc.
Nonin is a registered trademark of Nonin Medical, Inc.
© 2001 Nonin Medical, Inc.
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Table of Contents
About this Manual .........................................1-1
Guide to Symbols ...........................................2-1
Intended Use .................................................3-1
Indications for Use ......................................... 3-2
Pulse Oximeter Intended Use ....................... 3-2
Blood Pressure Monitor Intended Use ........ 3-2
Precautions for Use .......................................4-1
Description and Features ..............................5-1
Pulse Oximeter Features ................................ 5-2
NIBP Features ................................................. 5-4
System Features ............................................... 5-6
Advanced Features .......................................... 5-11
Using the Model 2120 ....................................6-1
Unpacking the Model 2120 ........................... 6-2
Installing the Batteries .................................... 6-3
Activating the Model 2120 ............................ 6-5
Verifying Model 2120 Operation .................. 6-5
Using the Pulse Oximeter .............................. 6-6
Taking Blood Pressure Measurements ........ 6-7
Automatic and Demand
NIBP Measurements ................................. 6-13
Calibrating Blood Pressure
on the Model 2120 ..................................... 6-14
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Table of Contents
Alarms and Limits .........................................7-1
Alarms ............................................................... 7-2
Alarm Summary ............................................... 7-6
Setting and Changing Alarm Limits ............. 7-8
Setting and Changing Alarm
and Pulse Volume ..................................... 7-13
Setting and Changing NIBP Settings ........... 7-15
Communication .............................................8-1
Memory Features ............................................ 8-2
Using the Model 2120 with
nVision™ Software .................................. 8-3
Real-Time Patient Data Output .................... 8-4
Care and Maintenance ..................................9-1
Cleaning the Model 2120 ............................... 9-2
Cleaning the Blood Pressure Arm Cuff ....... 9-2
Storage .............................................................. 9-2
Theory of Operation ......................................10-1
Pulse Oximetry ................................................ 10-2
Blood Pressure Measurement ....................... 10-4
Specifications .................................................11-1
Parts and Accessories ....................................12-1
Service and Support .......................................13-1
Warranty ........................................................14-1
Troubleshooting ............................................15-1
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1-1
Chapter 1
About this Manual
This manual describes the functions and explains the proper use of the
NONIN Model 2120 Pulse Oximeter and Noninvasive Blood Pressure
(NIBP) Monitor.
There are many ways to find information in this manual.
• The Table of Contents at the front of the manual can be used to find
specific chapters and sections.
• Each chapter contains a table of contents specific to that chapter.
• The bottom of every page contains the page number.
• The top of every left-hand page contains the name of the chapter to
which the manual is open.
NOTE: There are many contraindications, warnings, and
cautions throughout this manual. General
contraindications, warnings, and cautions are
listed in Chapter 4, “Precautions for Use.” This
manual must be read and its instructions followed
carefully before operating the Model 2120.
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2-1
Chapter 2
Guide to Symbols
The following table describes the symbols that are found on the Model
2120. For more specific information about these symbols, refer to
Chapter 5, “Description and Features.”
Symbol Description/Function
Main Alarm LED
%SpO2%SpO2Display
Pulse Rate Display
Pulse LED
Pulse Oximeter Sensor LED
Pulse Strength Bargraph LED
Systolic Systolic Pressure Display
Diastolic Diastolic Pressure Display
MAP Mean Arterial Pressure Display
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2-2
Guide to Symbols
Alarm Silence LED
Time LED
Month LED
Day LED
Year LED
Pulse Volume LED
Alarm Volume LED
Auto NIBP Mode LED
AC Power Adapter LED
Symbol Description/Function
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2-3
Battery LED
ON/STANDBY button
NIBP button
Auto NIBP Cycle Time button
NIBP History Review button
Initial Cuff Pressure button
Time/Date button
Volume button
Symbol Description/Function
mmHg
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2-4
Guide to Symbols
Alarm Silence button
Limits button
Plus button
Minus button
Attention: See Instructions for Use or related
materials.
Type BF Applied Part: Defibrillator Proof
(Patient isolation from electrical shock).
Applies to both pulse oximeter and NIBP.
UL Mark for Canada and the United States
with respect to electric shock, fire, and
mechanical hazards only in accordance with UL
2601-1 and CAN/CSA C22.1 No. 601.1.
CE Marking indicating conformance to EC
directive No. 93/42/EEC concerning medical
devices.
Serial Number (located under the battery
cover).
Symbol Description/Function
!
C
L
A
S
S
I
F
I
E
D
US
CUL
012
3
SN
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3-1
Chapter 3
Intended Use
This chapter describes the intended use of the NONIN Model 2120 Pulse
Oximeter and Noninvasive Blood Pressure (NIBP) Monitor.
ChapterContents
Page
3.1 Indications for Use .............................................................. 3-2
3.2 Pulse Oximeter Intended Use ............................................. 3-2
3.3 Blood Pressure Monitor Intended Use ................................ 3-2
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3-2
Intended Use
3.1 Indications for Use
The NONIN®Model 2120 Pulse Oximeter and NIBP Monitor
(Figure 3.1) is a portable device indicated for use in measuring and
displaying functional oxygen saturation of arterial hemoglobin (SpO2),
pulse rate, and blood pressure of adult and pediatric patients in hospitals,
medical facilities, and subacute environments. The Model 2120 is
intended for spot-checking and/or continuous monitoring of patients. Its
functions may be used separately or simultaneously.
Figure3.1TheModel2120PulseOximeterandNIBPMonitor.
3.2 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.
3.3 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 Model 2120 should be used for patients with arm circumferences of
18-42 cm.
MAP
mmHg
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4-1
Chapter 4
Precautions for Use
This section describes the contraindications, warnings, and cautions that
are important for the Model 2120 Pulse Oximeter and NIBP Monitor.
Read and follow all safety instructions in this chapter before using the
Model 2120.
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4-2
Precautions for Use
CONTRAINDICATIONS
Do not use the Model 2120 in a magnetic resonance imag-
ing (MRI) environment.
Do not use the blood pressure module of the Model 2120
on neonatal patients.
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4-3
WARNINGS
The Model 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 elec-
trosurgery; 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 Model 2120 only within the specified temperature
ranges: +32°F to +122°F (0°C to 50°C) for operating, and
-4°F to 122°F (-20°C to +50°C) for storage and transpor-
tation.
Do not use a damaged sensor or NIBP cuff under any cir-
cumstances.
All parts and accessories connected to the serial port of the
Model 2120 must be certified according to IEC Standard
EN 60950 or UL 1950 for data-processing equipment.
Use the Model 2120 with 300PS-XX, where XX represents
the power supply designation.
The Model 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 Model 2120 in an
explosive atmosphere or in the presence of flammable
anesthetics or gases.
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4-4
Precautions for Use
WARNINGS
Do not stretch the adhesive tape while applying the pulse
oximeter sensor.
Pulse oximeter readings might be affected while patients
are being defibrillated.
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 read-
ings or inability to operate the Model 2120.
Do not compress or hold the blood pressure cuff or cuff
hose while the Model 2120 is operating.
Do not apply the blood pressure cuff to an arm being used
for intravenous infusion or to any area with restricted cir-
culation.
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.
Ensure that all Model 2120 users know how to manually
remove the blood pressure cuff in case it fails to deflate.
The safety and effectiveness of the Model 2120 NIBP
function in pregnant women have not been established.
Do not operate the Model 2120 blood pressure module
unless it has been properly calibrated. Inaccurate blood
pressure readings can result if the Model 2120 has not
been calibrated properly. A calibration check is recom-
mended at least once every year.
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4-5
CAUTIONS
Federal law (USA) restricts this device to sale by or on the
order of a physician.
Read this entire manual carefully before using the Model
2120 Pulse Oximeter and NIBP Monitor.
Before using any sensor or NIBP cuff, carefully read the
Directions for Use.
Do not, under any circumstances, perform any testing or
maintenance on the Model 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 med-
ical 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 transmit-
ting 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 perfor-
mance of this device.
Verify that all visible indicators illuminate during the start-
up (initialization) sequence. If any indicator does not illu-
minate (except the AC Power Adapter LED), do not use
the Model 2120. Contact NONIN Customer Support for
assistance.
If the Model 2120 fails to respond as described, discon-
tinue 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.
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4-6
Precautions for Use
CAUTIONS
Batteries might leak or explode if used or disposed of
improperly.
Follow local governing ordinances and recycling instruc-
tions regarding disposal or recycling of the device and
device components, including batteries.
Do not immerse the Model 2120 or NONIN sensors in
water or any other liquids.
Do not place liquids on top of the Model 2120.
The Model 2120 is a precision electronic instrument. It
must be repaired by trained NONIN personnel only.
The Model 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 measure-
ment.
The Model 2120 might misinterpret motion as good pulse
quality (as indicated by a green pulse quality display). Min-
imize the patient’s finger motion as much as possible, or
change the type of sensor being used (e.g., ear clip).
Check the pulse oximeter sensor application site frequently
to determine the positioning of the sensor and the circula-
tion and skin sensitivity of the patient. Patient sensitivity to
the Model 2120 varies depending on medical status or skin
condition.
When using the 300PS-UNIV battery charger, ensure that
the AC cord is plugged into a grounded outlet.
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