Operator’s Manual
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Model 2500 PalmSAT
Pulse Oximeter
®
English
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
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EC
REP
licensed practitioner.
Consult Instructions for Use.
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
+1 (763) 553-9968
(800) 356-8874 (USA and Canada)
Fax: +1 (763) 553-7807
E-mail: info@nonin.com
Nonin Medical B.V.
Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands
+31 (0)13 - 79 99 040 (Europe)
Fax: +31 (0)13 - 79 99 042
E-mail: infointl@nonin.com
nonin.com
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
References to “Nonin” in this manual shall imply Nonin Medical, Inc.
Nonin, PalmSAT, PureLight and nVISION are registered trademarks or trademarks of Nonin
Medical, Inc.
Microsoft
®
and Windows® are registered trademarks of Microsoft Corporation.
© 2014 Nonin Medical, Inc.
7923-001-04
Contents
Indications for Use ........................................................................................ 1
Contraindications.................................................................................................... 1
Warnings ................................................................................................................ 1
Cautions ................................................................................................................. 2
Guide to Symbols .......................................................................................... 4
Displays and Indicators ................................................................................ 5
SpO2 Display .......................................................................................................... 5
Pulse Rate Display ................................................................................................. 5
Pulse Quality Display.............................................................................................. 5
Low Battery Indicator.............................................................................................. 5
Sensor Fault or Inadequate Signal Display ............................................................ 5
Using the PalmSAT Pulse Oximeter ............................................................ 6
Unpacking the Model 2500..................................................................................... 7
Installing and Using the Batteries........................................................................... 8
Important Notes about Battery Use ........................................................................ 9
With AA Batteries................................................................................................ 9
With Rechargeable NiMH Battery Pack .............................................................. 9
Recharging Batteries (NiMH Battery Pack only)................................................... 10
Connecting the Sensor ......................................................................................... 10
Power On/Off........................................................................................................ 10
Power On Self-Test .............................................................................................. 10
Monitoring............................................................................................................. 11
Detailed Operation....................................................................................... 12
Setup Mode .......................................................................................................... 12
Entering Setup Mode ........................................................................................ 12
Making Selections in Setup Mode..................................................................... 12
Care and Maintenance................................................................................. 14
Visual Indicators .......................................................................................... 15
Memory Functions....................................................................................... 16
Memory Download................................................................................................ 16
Downloading the Data Stored in Memory ......................................................... 16
Clearing the Memory ............................................................................................ 17
Clear Memory Mode ......................................................................................... 17
Choosing Calendar and Clock Settings................................................................ 17
Communications.......................................................................................... 18
Serial Output......................................................................................................... 18
Connecting the Device into a Medical System ..................................................... 19
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Contents (Continued)
Service, Support and Warranty...................................................................20
Warranty................................................................................................................21
Parts and Accessories.................................................................................22
Troubleshooting ...........................................................................................23
Technical Information ..................................................................................25
Manufacturer’s Declaration ...................................................................................25
Equipment Response Time...................................................................................29
Testing Summary ..................................................................................................30
SpO
Accuracy Testing .....................................................................................30
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Pulse Rate Motion Testing.................................................................................30
Low Perfusion Testing .......................................................................................30
Principles of Operation..........................................................................................30
Specifications ........................................................................................................31
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Figures
Figure 1. Displays, Indicators and Buttons................................................................. 6
Figure 2. Rear View.................................................................................................... 7
Figure 3. Installing Batteries....................................................................................... 9
Figure 4. Connecting a Sensor................................................................................. 10
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Tables
Table 1. Labeling Symbols......................................................................................... 4
Table 2. Adjustable Parameters and Settings.......................................................... 12
Table 3. Pulse Oximeter Sensor Connector Pin Assignments................................. 18
Table 4. Electromagnetic Emissions........................................................................ 25
Table 5. Electromagnetic Immunity.......................................................................... 26
Table 6. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity.... 27
Table 7. Recommended Separation Distances ....................................................... 28
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Indications for Use
Indications for Use
The Nonin® Model 2500 Pulse Oximeter is indicated for use in measuring and displaying
functional oxygen saturation of arterial hemoglobin (SpO
neonatal patients. The device is intended for continuous monitoring and/or spot-checking of
patients during both motion and no-motion conditions, and for patients who are well or poorly
perfused.
Contraindications
Do not use this device in an MR environment.
Explosion Hazard: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or
gasses.
This device is not defibrillation proof per IEC 60601-1.
) and pulse rate for adult, pediatric, and
2
Warnings
This device 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 of this device may be affected by the use of an electrosurgical unit (ESU).
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.
®
To avoid patient injury, use only with Nonin-branded PureLight
manufactured to meet the accuracy specifications for Nonin Pulse Oximeters. Using other manufacturers’
sensors can result in improper pulse oximeter performance.
To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and
accessories before use.
No modifications to this device are allowed as it may affect device performance.
Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the
sensor.
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement,
strangulation, or injury to the patient.
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.
pulse oximeter sensors. These sensors are
The use of accessories, sensors, cables, and power supplies other than those specified in the Parts and
Accessories List may result in increased electromagnetic emission and/or decreased immunity of this device.
This device must be able to measure the pulse properly to obtain an accurate SpO
nothing is hindering the pulse measurement before relying on the SpO
Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
measurement.
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measurement. Verify that
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1
Indications for Use
Warnings (Continued)
Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material.
Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the
sensor.
The device turns off after approximately 10 minutes when at critically low battery capacity.
Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.
Cautions
Before use, carefully read the Instructions for Use provided with the sensors.
This device is not an apnea monitor.
Verify that all visible indicators illuminate during the startup (initialization) sequence. If any indicator is not lit, do
not use the device. Contact Nonin Technical Service for assistance.
The presence of a defibrillator may interfere with the performance of this device.
This device may not work on all patients. If you are unable to achieve stable readings, discontinue use.
This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as
good pulse quality. In some circumstances, however, the device may still interpret motion as good pulse quality.
Minimize patient motion as much as possible.
Ear Clip and Reflectance sensors are not recommended for pediatric or neonatal use. The accuracy of these
sensors has not been established for pediatric or neonatal use.
Do not autoclave or immerse the device or sensors in liquid. Do not expose the device or components to
excessive moisture or liquids.
Do not use caustic or abrasive cleaning agents on the device or the sensors.
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.
Replace the batteries as soon as possible after a low-battery indication. Always replace the batteries with fully
charged batteries.
Use only Nonin-specified battery types with this device.
Do not use fully charged and partially charged batteries at the same time. This may cause the batteries to leak.
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.
Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of
the device and device components, including batteries.
Batteries may leak or explode if used or disposed of improperly.
Remove the batteries if the device will be stored for more than 1 month.
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Indications for Use
- excessive ambient light
- excessive motion
- electrosurgical interference
- blood flow restrictors (arterial catheters, blood pressure
cuffs, infusion lines, etc.)
- moisture in the sensor
- improperly applied sensor
- incorrect sensor type
- inadequate signal
- venous pulsations
- anemia or low hemoglobin concentrations
- cardiogreen and other intravascular dyes
- carboxyhemoglobin
- methemoglobin
- dysfunctional hemoglobin
- artificial nails or fingernail polish.
Cautions (Continued)
This equipment complies with IEC 60601-1-2 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 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.
This device’s display will go blank after 10 seconds of inadequate signals. The data update period is every
1.5 seconds.
Portable and mobile RF communications equipment can affect medical electrical equipment.
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:
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 UL1950 for data-processing equipment.
This device is a precision electronic instrument and must be repaired by trained Nonin personnel only. 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.
Any sign or evidence of opening the system, field service by non-Nonin personnel, tampering, or any kind of
misuse or abuse of the system, shall void the warranty in its entirety.
Replace batteries within 30 seconds to avoid losing settings (date, time, and patient data stored in memory) or
corrupting data.
Radios and cell phones or similar devices can affect the equipment and must be kept at least 2 meters (6.5 feet)
away from equipment.
Failure of a network data coupling (serial cable/connectors/wireless connections) will result in loss of data
transfer.
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Guide to Symbols
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Guide to Symbols
This table describes the symbols that are found on the Model 2500 and in this manual.
Table 1: Labeling Symbols
Symbol Description
Consult Instructions for Use.
Follow Instructions for Use.
Type BF Applied Part (Patient isolation from 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 and CAN/CSA-C22.2
No. 601.1.
CE Marking indicating conformance to EC directive No. 93/42/EEC concerning
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medical devices.
IP32
%SpO
Serial Number (located under the back cover).
Protected against vertically falling water drops when enclosure is tilted up
to 15 degrees and ingress of solid foreign objects greater than or equal to 2.5 mm
(0.1 in.) in diameter per IEC 60529.
Indicates separate collection for electrical and electronic equipment (WEEE).
Authorized Representative in the European Community.
Manufacturer
%SpO2 Display
2
Pulse Rate Display
Pulse Quality Display
Low Battery LED
No Alarms
Front Panel Buttons
On/Off
Advance
4
Displays and Indicators
Displays and Indicators
SpO2 Display
The SpO2 display is the upper numeric display (identified by the %SpO2 symbol). This 3-digit
light-emitting diode (LED) display shows the current oxygen saturation percentage.
Pulse Rate Display
The Pulse Rate display is the lower numeric display (identified by the symbol). This 3-digit
LED display shows the pulse rate in pulses per minute.
Pulse Quality Display
The Pulse Quality display (identified by the symbol) is a tricolor LED that blinks once for each
detected pulse. The Pulse Quality display changes color to indicate changes in the pulse
waveform signal that may affect the SpO
• Green indicates a good pulse strength signal.
• Amber indicates a marginal pulse strength signal. To improve signal quality, reposition the
sensor, try a different sensor type, reduce patient movement, or improve the site’s circulation.
• Red indicates an inadequate pulse strength signal. While the Pulse Quality display is red,
SpO
and pulse rate values are not updated. After about 10 seconds, the values are replaced
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with dashes, indicating that readings are not possible.
data. It may blink green, amber or red.
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Low Battery Indicator
When batteries are critically low, the digital displays will go blank, and the Pulse Quality display
will blink amber or red, but not green. After 10 minutes at critically low battery capacity, the pulse
oximeter will shut off automatically.
Sensor Fault or Inadequate Signal Display
If the device determines that a sensor fault exists (a sensor disconnect, failure, misalignment or
incompatibility with the monitor) or if a pulse oximeter sensor signal is no longer detected, a dash
(-) appears in the leftmost position of the SpO
for 10 seconds if the pulse oximeter sensor fault or the inadequate signal continues.
If the sensor fault or the inadequate signal is not corrected, the frozen readings and the dash in
the leftmost position will be replaced by dashes in the middle of both the SpO
displays after 10 seconds.
When the sensor fault or the inadequate signal is corrected, the SpO
return to normal operation.
display. The readings that are displayed will freeze
2
and the Pulse Rate
2
and pulse rate displays will
2
5
Using the PalmSAT Pulse Oximeter
SpO2
Display
On / Off
Button
Pulse Quality
Display
(Tricolor)
Pulse Rate
Display
Pulse Oximeter
Sensor
Connector
Advance
Button
Low Battery
Indicator
Using the PalmSAT Pulse Oximeter
The Model 2500 PalmSAT is a digital handheld pulse oximeter that displays numerical values for
blood oxygen saturation (%SpO
This device will typically operate for 80 hours continuously between alkaline battery replacements,
or for 40 hours with the Model 2500B Rechargeable NiMH (Nickel Metal Hydride) Battery Pack
(optional). The device requires no routine calibration or maintenance other than replacement of
alkaline batteries or recharging the optional battery pack with the Model 2500C Charger Stand
(refer to the Model 2500C Operator’s Manual).
) and pulse rate.
2
The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO
) by
2
measuring the absorption of red and infrared light passing through perfused tissue. Changes in
absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen
saturation and pulse rate.
Figure 1: Displays, Indicators and Buttons
Oxygen saturation and pulse rate values are displayed by light-emitting diode (LED) digital
displays. On each detected pulse, the Pulse Quality display blinks. Patient pulse quality signals
are graded as good, marginal, or inadequate and are indicated as such by the Pulse Quality
display blinking green, amber or red, respectively. This simple method gives the user a pulse-bypulse visual indication of waveform signal quality without requiring the user to perform complex
waveform analysis.
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