Operator’s Manual

Model 2500A PalmSAT®

Pulse Oximeter with Alarms

0123 English
.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
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: [email protected]

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: [email protected]

nonin.com

0123

EC REP

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.
7923-101-04
 Contents
Indications for Use ........................................................................................ 1
Contraindications.................................................................................................... 1
Warnings ................................................................................................................ 1
Cautions ................................................................................................................. 2
Guide to Symbols .......................................................................................... 5
Displays and Indicators ................................................................................ 6
SpO2 Display .......................................................................................................... 6
Pulse Rate Display ................................................................................................. 6
Pulse Quality Display.............................................................................................. 6
Low Battery Indicator.............................................................................................. 6
Sensor Fault Display .............................................................................................. 7
Alarm Bar................................................................................................................ 7
Alarm Silence Indicator........................................................................................... 7
Pulse Rate Tone..................................................................................................... 7
Using the PalmSAT Pulse Oximeter ............................................................ 8
Unpacking the Model 2500A .................................................................................. 9
Installing and Using the Batteries ......................................................................... 10
Important Notes about Battery Use ...................................................................... 11
With AA Batteries .............................................................................................. 11
With Rechargeable NiMH Battery Pack ............................................................ 11
Recharging Batteries (NiMH Battery Pack only)................................................... 12
Connecting the Sensor ......................................................................................... 12
Power On/Off........................................................................................................ 12
Power On Self-Test .............................................................................................. 12
Monitoring............................................................................................................. 13
Detailed Operation....................................................................................... 14
Setup Mode .......................................................................................................... 14
Entering Setup Mode ........................................................................................ 14
Making Selections in Setup Mode..................................................................... 14
Care and Maintenance................................................................................. 16
Alarm Functions .......................................................................................... 17
High and Medium Priority Alarms ......................................................................... 17
Adjusting Alarm Settings ...................................................................................... 18
Recalling Previous Alarm Settings ....................................................................... 18
Reviewing Alarm Settings..................................................................................... 19
Silencing Audible Alarms...................................................................................... 19
System Fault Alarms ............................................................................................ 19
Memory Functions....................................................................................... 20
Memory Playback ................................................................................................. 20

i
 Contents (Continued)
Playing Back the Data Stored in Memory ..........................................................20
Clearing the Memory.............................................................................................21
Choosing Memory Clear Settings ......................................................................21
Choosing Calendar and Clock Settings ................................................................21
Communications ..........................................................................................22
Serial Output .........................................................................................................22
Connecting the Device into a Medical System ......................................................22
Service, Support and Warranty...................................................................24
Warranty................................................................................................................25
Parts and Accessories.................................................................................26
Troubleshooting ...........................................................................................27
Technical Information ..................................................................................30
Manufacturer’s Declaration ...................................................................................30
Equipment Response Time...................................................................................34
Testing Summary ..................................................................................................35
SpO2 Accuracy Testing .....................................................................................35
Pulse Rate Motion Testing.................................................................................35
Low Perfusion Testing .......................................................................................35
Principles of Operation..........................................................................................35
Specifications ........................................................................................................36

ii
 Figures
Figure 1. Displays, Indicators and Buttons................................................................. 8
Figure 2. Rear View.................................................................................................... 9
Figure 3. Installing Batteries..................................................................................... 11
Figure 4. Connecting a Sensor................................................................................. 12

iii
 Tables
Table 1. Labeling Symbols......................................................................................... 5
Table 2. Adjustable Parameters and Settings.......................................................... 15
Table 3. High and Medium Priority Alarms .............................................................. 17
Table 4. Alarm Limits ............................................................................................... 18
Table 5. Pulse Oximeter Sensor Connector Pin Assignments................................. 22
Table 6. Electromagnetic Emissions........................................................................ 30
Table 7. Electromagnetic Immunity.......................................................................... 31
Table 8. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity.... 32
Table 9. Recommended Separation Distances ....................................................... 33

iv
Indications for Use

Indications for Use

The Nonin® Model 2500A PalmSAT® Pulse Oximeter with Alarms is indicated for use in measuring
and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult,
pediatric, and 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.

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® 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.

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.

Verify all alarm settings and limits during system startup to ensure that they are set as intended.

A hazard can exist if different presets are used on multiple 2500A monitors in one care area.

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.

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.

1
 Indications for Use

Warnings (Continued)
This device must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that
nothing is hindering the pulse measurement before relying on the SpO2 measurement.

Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.

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.

Because operating environments vary, use caution to ensure that all audible alarms and indicators can be heard.
Users must determine the acceptable audible distance of all alarms.

Do not place this device in an environment where its speaker opening may become blocked; alarms may
become muffled or inaudible.

Turning off the alarm volume creates a situation that is not compliant with relevant safety standards. The alarm
silence indicator is lit solid when the alarm volume is turned off or set below 45 dBA.

When a system fault occurs, the patient will no longer be monitored.

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.

The device turns off after approximately 10 minutes when at low battery capacity.

Before changing the batteries, make sure the device is off and the sensor is not attached to a digit.

Cautions
Before use, carefully read the package insert provided with the sensors.

This device is not an apnea monitor.

Verify that all visible indicators illuminate and that an audible indicator sounds during the startup (initialization)
sequence. If any indicator is not lit or the audible indicator does not sound, do not use the device. Contact Nonin
Technical Service for assistance.

Review all limits to ensure they are appropriate for the patient.

Setting alarm limits to extremes can render the alarm system useless.

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.

2
Indications for Use

Cautions (Continued)
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.

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:
- excessive ambient light - venous pulsations
- excessive motion - anemia or low hemoglobin concentrations
- electrosurgical interference - cardiogreen and other intravascular dyes
- blood flow restrictors (arterial catheters, blood pressure - carboxyhemoglobin
cuffs, infusion lines, etc.) - methemoglobin
- moisture in the sensor - dysfunctional hemoglobin
- improperly applied sensor - artificial nails or fingernail polish
- incorrect sensor type - a sensor not at heart level.
- inadequate signal

3
 Indications for Use

Cautions (Continued)
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.

4
Guide to Symbols

Guide to Symbols
This table describes the symbols that are found on the Model 2500A and in this manual.
Table 1: Labeling Symbols

Symbol Description

! CAUTION!

Consult Instructions for Use.

Follow Instructions for Use.

Type BF Applied Part (Patient isolation from electrical shock).

LA
SSI FI E UL Mark for Canada and the United States with respect to electric shock, fire, and
C

C UL US mechanical hazards only in accordance with UL 60601-1 and CAN/CSA-C22.2

No. 601.1.

0123
CE Marking indicating conformance to EC directive No. 93/42/EEC concerning
medical devices.

SN Serial Number (located under the back cover).

Protected against vertically falling water drops when enclosure is tilted up to
IP32 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).

EC REP Authorized Representative in the European Community.

Manufacturer

%SpO2 %SpO2 Display

Pulse Rate Display

Pulse Quality Display

Low Battery LED

Alarm Silence LED

Front Panel Buttons

On/Off

Advance

5
 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. This display
flashes for SpO2 alarms.

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. This display flashes for Pulse Rate alarms.

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 SpO2 data. It may blink green, amber or red.
• Green indicates a good pulse strength
• Amber indicates a marginal pulse strength. To improve signal quality, reposition the
sensor, try a different sensor type, eliminate patient movement, or improve the site’s
circulation.
• Red indicates an inadequate pulse strength. While the Pulse Quality display is red,
SpO2 and pulse rate values are not updated. After about 10 seconds, the values are
replaced with dashes, indicating that readings are not possible.

Low Battery Indicator

Low and critically low battery capacity is indicated with a flashing Low Battery indicator and a
medium priority alarm. When batteries are critically low, the digital displays will go blank, and the
Pulse Quality display will blink amber or red, but not green. Any SpO2 or pulse rate alarms in effect
when critically low battery capacity is reached will be latched, and flashing dashes will appear on
the corresponding display. After 10 minutes at critically low battery capacity, the pulse oximeter
will shut off automatically.

6
Displays and Indicators

Sensor Fault 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 left-most digit of the SpO2 display. The readings that are displayed will freeze for
10 seconds if the pulse oximeter sensor fault or the inadequate signal continues. A sensor fault is
a medium priority alarm.
If the sensor fault or the inadequate signal is not corrected, the frozen readings and the left-most
dash will be replaced by dashes in the middle digit of both the SpO2 and the Pulse Rate displays,
10 seconds after the first dash appeared.
When the sensor fault or the inadequate signal is corrected, the SpO2 and pulse rate displays will
return to normal operation.

Alarm Bar
The Alarm Bar flashes amber or red, indicating medium or high priority alarms, respectively. This
indicator is located near the top of the device.

Alarm Silence Indicator

The Alarm Silence indicator (identified by the symbol) is located to the left of the On/Off button.
Whenever the Alarm Silence indicator is flashing, all audible alarms are temporarily silenced. If the
alarm volume is set to “off,” the Alarm Silence indicator is lit solidly.

Pulse Rate Tone

When the Pulse Rate tone is active, a beep sounds for each detected pulse. This beep changes
in pitch with SpO2 values. The default volume is OFF. During normal operation, the volume can be
changed (off, low, or high) by momentarily pressing the advance button.

7
 Using the PalmSAT Pulse Oximeter

Using the PalmSAT Pulse Oximeter

The Model 2500A PalmSAT is a digital handheld pulse oximeter that displays numerical values
for blood oxygen saturation (%SpO2) and pulse rate. It provides audible and visual alarms for both
medium and high priority conditions.
This device will typically operate for 60 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).
The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by
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.

Pulse Oximeter
Sensor
Connector
Alarm Bar
(Bicolor)

Speaker
SpO2
Display
Pulse Quality
Display (Tricolor)
Pulse Rate
Display
Advance Button

Low Battery
Indicator
On / Off Button

Alarm Silence
Indicator

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-by-
pulse visual indication of waveform signal quality without requiring the user to perform complex
waveform analysis.

8
Using the PalmSAT Pulse Oximeter

The Model 2500A Pulse Oximeter may be used with a variety of Nonin-branded PureLight pulse
oximeter sensors.
A sensor disconnect or malfunction is indicated by an inadequate Pulse Quality display blinking
and/or a dash to the left of the SpO2 value on the LED display. When adequate pulse signals are
not received, the SpO2 and/or pulse rate numerical values will be replaced by dashes. Low and
critically low battery conditions will be indicated by the Low Battery indicator.

IP32
See Accompanying
Documents
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
MODEL 2500A 4 X 1.5V AA
LA
SSIFIE PULSE OXIMETER IEC LR6

D
C
UL 60601-1
C UL US 30EM 0123
US PATENT # Re. 33,643
5822-500-06

Battery Cover
Latch
Battery
Cover

Figure 2: Rear View

Unpacking the Model 2500A

The Model 2500A complete system includes the following items:
• 1 Model 2500A Pulse Oximeter
• 1 Model 2500A Operator’s Manual on CD
• 1 Nonin Pulse Oximeter Sensor
• 4 AA-Size Alkaline Batteries
Confirm that the items listed are packed with the system. If any item on this list is missing or
damaged, contact your distributor. Contact the carrier immediately if the shipping carton is
damaged.

9
 Using the PalmSAT Pulse Oximeter

Installing and Using the Batteries

The Model 2500A can be powered by 4 AA-size alkaline batteries, or by the optional
Rechargeable NiMH Battery Pack, Model 2500B.

! CAUTION: Use only Nonin-specified battery types with this device.

Low and critically low battery capacity is indicated with a flashing Low Battery indicator and a
medium priority alarm. When batteries are critically low, the digital displays will go blank, and the
Pulse Quality indicator will blink amber or red, but not green. Any SpO2 or pulse rate alarms in
effect when critically low battery capacity is reached will be latched, and flashing dashes will
appear on the corresponding display. After 10 minutes at critically low battery capacity, the pulse
oximeter will shut off automatically.
.

WARNING: The device turns off after approximately 10 minutes when at critically low
battery capacity.

WARNING: Before changing the batteries, make sure the device is off and the sensor
is not applied to a digit.

CAUTION: Replace the batteries as soon as possible after a low-battery indication.

! Always replace the batteries with fully charged batteries.

1. Press the battery cover latch, and remove the battery cover on the bottom of the unit.
2. Insert four new AA-size alkaline batteries or a Rechargeable NiMH Battery Pack. Be sure
to insert the batteries in the correct position, as indicated by the polarity markings (+ and 
inside the battery compartment. Proper battery positioning is essential for correct
operation.
3. Replace the battery cover and turn on the device. If the unit does not turn on, see
“Troubleshooting.”

CAUTION: Replace batteries within 30 seconds to avoid losing settings (date, time,
! and patient date stored in memory) or corrupting data.

10
Using the PalmSAT Pulse Oximeter

AA-size Battery Pack

Alkaline
Batteries

Battery
Orientation

Figure 3: Installing Batteries

Important Notes about Battery Use

Four AA alkaline batteries provide the device with approximately 60 hours of continuous operation,
while the Rechargeable NiMH Battery Pack provides approximately 40 hours of continuous operation.
Clock/calendar settings can significantly affect battery storage life. Batteries drain during
storage, but they drain much more quickly when the unit’s clock/calendar functions are set. Refer
to “Clock and Calendar Settings” for more information.

With AA Batteries
• If the clock/calendar is not set when the unit is stored, alkaline batteries will need
replacement in 10-12 months if the unit has not been used.
• If the clock/calendar is set when the unit is stored and if the unit has not been used,
alkaline batteries will require replacement in about 6 weeks.
• Using the oximeter will shorten the required replacement time.

With Rechargeable NiMH Battery Pack

• If the clock/calendar is not set when the unit is stored, and if the unit has not been used,
the Rechargeable NiMH Battery Pack will need recharging at least every 2 months.
• If the clock/calendar is set when the unit is stored, and if the unit has not been used, the
Rechargeable NiMH Battery Pack will need recharging at least every 3 weeks.
• Using the oximeter will shorten the required recharging time.

11
 Using the PalmSAT Pulse Oximeter

Recharging Batteries (NiMH Battery Pack only)

• Completely recharging the NiMH battery pack requires approximately 180 minutes when
the unit is completely discharged.
• The expected useful life of the Rechargeable NiMH battery pack is 500 charge/
discharge cycles, or approximately 10 years, whichever is first. The battery pack must
be charged at least once each year to maintain optimal battery life.
• AA alkaline batteries cannot be recharged in the charging stand.

Connecting the Sensor

Connect the pulse oximeter sensor (with the Nonin logo facing up) to the top of the device as
shown. Ensure that the sensor is firmly plugged in. Refer to “Specifications” or to the specific
sensor package insert for pulse oximeter sensor positioning information.

Figure 4: Connecting a Sensor

Power On/Off
• Turn on the device by pressing and releasing the On/Off button on the front of the unit.
• Turn off the device by pressing and holding the On/Off button for approximately 2 seconds.
To conserve battery life, the device automatically powers off after 10 minutes of inactivity. Inactivity
is indicated by dashes on the displays and may result from an improperly connected or positioned
sensor, or from an inadequate patient pulse signal.

Power On Self-Test
When the Model 2500A is turned on for normal operation, the unit will cycle through a startup/
initialization sequence before displaying valid data. During startup, always check for any missing
indicators or LED display segments and ensure that the audible indicator sounds. If any indicator is
not functioning, do not use the device. Contact Nonin Technical Service for repair or replacement.
During its normal startup sequence, the device will cycle as follows:
• “888 888” appears briefly in the SpO2 and Pulse Rate displays.
• the amber Low Battery and Alarm Silence indicators turn on steadily for a few seconds.

12
Using the PalmSAT Pulse Oximeter

• the Pulse Quality display turns red for 1 second, then green for 1 second, then shuts off,
while the Alarm Bar turns red for 1 second, then amber for 1 second.
• the clock time currently set in the memory (in hours and minutes, 04 41 for example)
appears briefly in the displays.
• the software revision numbers (display in the following order, each for approximately
1 second): Main revision “r” + 3 digits; Memory revision “n” “n” (for m) + 3 digits; Sound
revision “s” + 3 digits.
• three audible beeps sound.
• (two dashes) appear in the displays until a valid pulse signal is detected.

NOTES:
• The two-minute alarm silence feature is automatically enabled immediately after the startup
sequence.
• This startup sequence varies slightly when entering setup mode at power on.

Monitoring
Verify that the pulse oximeter sensor is properly positioned on the patient. Ensure that the pulse
oximeter is sensing adequate pulse quality by:
• verifying that the Pulse Quality display is blinking green and
• verifying that the Pulse Rate and SpO2 displays are displaying readings and
• verifying that blinking of the Pulse Quality display is in time with the pulse rate for at least
10 seconds
If the Pulse Quality display is blinking red or amber or is blinking erratically, reposition the sensor
or replace the sensor.
If the sensor is not properly positioned, or no sensor is attached to the pulse oximeter after startup
(a few seconds after powering on), both the SpO2 and Pulse Rate displays will display a single
dash until a valid pulse signal is detected.

13
 Detailed Operation

Detailed Operation
All functions of the Model 2500A are controlled by the On/Off and Advance buttons located
on the front of the unit.

Setup Mode
Setup mode is used to adjust alarm, memory clear, and memory playback functions, as well as to
set the calendar and clock. In Setup mode, the Advance and On/Off buttons are used to make
all selections.

NOTE: Setting the month to “00” disables the calendar and clock functions and helps
conserve battery life.

Entering Setup Mode

1. With the unit off, press and hold the Advance button while pressing and then releasing
the On/Off button.
2. Release the advance button when 888 888 is displayed on the SpO2 and Pulse Rate
displays. The clock time currently set in the memory, 04 41 for example, appears briefly
in the displays, and then rCL no appears.

Making Selections in Setup Mode

WARNING: Verify all alarm settings and limits during system startup to ensure that
they are set as intended.

CAUTION: Review all limits to ensure they are appropriate for the patient.
!
CAUTION: Setting alarm limits to extremes can render the alarm system useless.
!
1. When entering Setup mode, rCL no is displayed. (This indicates that Recall Alarms is
the setting being adjusted, and that the default value is “no.” See Table 2.) Press and
release the Advance button to change the value for this setting (or press and hold the
Advance button to scroll quickly through the range of adjustable values).
2. When the desired value appears, press and release the On/Off button to store the value
and advance to the next adjustable parameter, as listed in the following table.
3. Continue this process until all settings are chosen.
When the setting sequence is complete, the device exits Setup mode, automatically displays the
alarm settings in effect, and is then ready to begin normal operation.

14
Detailed Operation

Table 2: Adjustable Parameters and Settings

Appears in SpO2 Range of Values Appears in Default

Setting
Display Pulse Rate Display Value

Recall Alarm Settings1 rCL yES or no no

SpO2 Low Alarm 02L 50 - 95, 0FF 85

Heart Rate High Alarm H H 75 - 275, 0FF 200

Heart Rate Low Alarm H L 30 - 110, 0FF 50

SpO2 High Alarm 02H 80 - 100, 0FF 0FF

Audible Alarms Adb Hi, Lo, 0FF Hi

Memory Clear2 CLr yES or no no

Delete (confirm clear) dEL yES or no no

Year y 00 - 99 07

Month nn 00 - 12 00

Day d 01 - 31 00

Hour h 00 - 23 00

Minute nn 00 - 59 00

Notes:
1) Choosing “yes” for rCL (Recall Alarm Settings) will recall previous alarm settings and exit setup
mode.
2) Choosing “yes” for both the CLr and dEL settings (the memory clear function) will clear the memory
and exit setup mode.

15
 Care and Maintenance

Care and Maintenance

Clean the device separately from the sensors. For instructions on cleaning pulse oximeter
sensors, refer to the respective sensor instructions for use.
The OxitestPlus7 by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.

CAUTION: Do not autoclave or immerse the device or sensors in liquid. Do not

! expose the device or components to excessive moisture or liquids.

CAUTION: Do not use caustic or abrasive cleaning agents on the device or the
! sensors.

Clean the device with a soft cloth dampened with isopropyl alcohol. Do not pour or spray any
liquids onto the device, and do not allow any liquid to enter any openings in the device. Allow the
device to dry thoroughly before reusing.

16
Alarm Functions

Alarm Functions
This section describes the alarm functions of the Model 2500A.
The intended operator’s position for correctly perceiving a visual alarm signal and its priority is
1 meter (3.3 feet).

High and Medium Priority Alarms

The Model 2500A features audible and visual alarms that indicate both high and medium priority
alarm conditions. In general, high priority alarms are patient-specific and are indicated by a
flashing red alarm bar and a high priority audible alarm signal. High priority alarms are sounded
as follows: three beeps, a pause, and two beeps followed by an approximate 10-second pause.
This cycle repeats until silenced.
Medium priority alarms are generally equipment-specific, and are indicated by a flashing amber
alarm bar and a medium priority audible alarm signal. Medium priority alarms are sounded as
follows: three beeps, an approximate 25-second pause and three beeps.
The following table describes alarm conditions, visible indication, and priorities.

WARNING: When a system fault occurs, the patient will no longer be monitored.

Table 3: High and Medium Priority Alarms

Condition Visible Indication Alarm Priority

The SpO2 display flashes in sync with the Alarm Bar.

SpO2 high or low If in battery critical state, three dashes are inserted in High
the display and flash in sync with the Alarm Bar.

The pulse display flashes in sync with the Alarm Bar.

Pulse Rate high or low If in battery critical state, three dashes are inserted in High
the display and flash in sync with the Alarm Bar.

Pulse Wave form Pulse Quality LED blinks red, SpO2 and heart rate
High
amplitude is inadequate LED go to dashes in 10 sec.

Pulse Quality LED blinks. Display “dash” sign in

Inadequate Signal (i.e.,
leftmost SpO2 LED, freeze both numeric displays for
sensor dislodgement, Medium
10 seconds, display “dash” sign in middle LED of
unusable signal)
SpO2 and pulse rate numeric displays.

Sensor fault l (i.e., Pulse Quality LED is blank. Display “dash” sign in
sensor disconnect, bad leftmost SpO2 LED, freeze both numeric displays for
Medium
cable, Nonin 10 seconds, display “dash” sign in middle LED of
incompatible sensor) SpO2 and pulse rate numeric displays.
SpO2 or pulse rate data
Display “dash” sign in middle LED of SpO2 and pulse
not adequate for more Medium
rate numeric displays (i.e. out-of-track indication).
than 20 seconds

17
 Alarm Functions

Table 3: High and Medium Priority Alarms (Continued)

Condition Visible Indication Alarm Priority

Pulse rate date not

updated for more than Pulse rate numeric display goes to dashes. Medium
30 seconds

Battery low indicator flashing (2500A). No other

Battery marginal Medium
displays are affected.

Battery low indicator flashing, blank all SpO2 and

Battery critical pulse rate numeric LEDs, latch pulse quality at red or Medium
yellow, but not green.

Sound Module or
Display error code. Medium
system failure detected

Adjusting Alarm Settings

WARNING: 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.

Users may adjust the alarm limits for upper and lower SpO2 and Pulse Rate alarms and alarm
volume as shown below.
Table 4: Alarm Limits

Alarm Limit Default Adjustment Options Increments

SpO2 High Off Off, 80–100 1%

SpO2 Low 85% Off, 50–95 1%

Pulse Rate High 200 BPM Off, 75–275 5 BPM

Pulse Rate Low 50 BPM Off, 30–110 5 BPM

Alarm Volume Hi Off, Lo, Hi N/A

Adjusting alarm settings is only possible when the device is in Setup mode. For every power on
in which alarm settings have not been recalled or adjusted in Setup mode, the default alarm
settings remain in effect.

Recalling Previous Alarm Settings

The most recently adjusted alarm limits and volume may be recalled each time the device is
started up. These alarm settings are retained and available for recall for approximately
30 seconds after batteries are removed.

18
Alarm Functions

CAUTION: Replace batteries within 30 seconds to avoid losing settings (date, time,
! and patient date stored in memory) or corrupting data.

NOTE: The SpO2 Low Alarm setting will default to 85% if set below 85%, and anytime the
unit is powered off.

1. With the unit off, press and hold the Advance button while pressing and then releasing
the On/Off button.
This enters Setup mode and displays rCL no—indicating that Recall Alarms is the
parameter being adjusted, and that the default value is “no.”
2. Press and release the Advance button.
This changes the Recall Alarms value to yES—indicating that previously-adjusted alarm
settings will be recalled.
3. Press and release the On/Off button to select yES and recall all previously-adjusted
alarm and volume settings.
All recalled settings are individually flashed on the display screen before the unit begins normal
operation.

NOTE: Setup mode exits automatically after Recall Alarms setting is selected.

Reviewing Alarm Settings

At any time during normal operation, alarm limits and volume settings can be reviewed by pressing
and holding the Advance button for one second. All settings are then individually flashed on the
display screen.

NOTE: To stop the alarm review early and return to normal operation, press the Advance
button momentarily.

Silencing Audible Alarms

Audible alarms are automatically silenced for the first 2 minutes of normal operation. Momentarily
press the On/Off button to temporarily silence audible alarms (2 minute silence) during normal
operation. Press the On/Off button again to cancel the temporary alarm silence.

System Fault Alarms

If the device determines that a system fault exists, an error message (e.g., Err E01) appears
in the SpO2 and Pulse Rate displays, along with medium priority alarm indicators. A system fault
has also occurred if the displays and indicators are blank but a continuous audible alarm is
sounding. Attempt to clear the error by turning the device off and on. If the problem persists,
contact Nonin Technical Service.

WARNING: When a system fault occurs, the patient will no longer be monitored.

19
 Memory Functions

Memory Functions
Each time the Model 2500A is turned on (except during Setup mode), data are automatically
collected in memory. The device can collect and store up to 72 hours of SpO2 and pulse rate
information.

NOTE: Only recording sessions longer than 1 minute are stored in memory. Memory will
clear approximately 30 seconds after removing the batteries. Replace batteries immediately
to avoid losing stored data.

Nonin’s nVISION data management software is available for use with Microsoft Windows
operating systems.
The memory in the device functions as an “endless loop.” When the memory fills up, the unit
begins overwriting the oldest data with the newest.
Each time the device is turned on, the current time/date information (if the clock is set correctly)
is stored in memory to allow quick differentiation of recording sessions. Patient SpO2 and pulse
rate are sampled and stored every 4 seconds.
Oxygen saturation values are stored in 1% increments in the range of 0 to 100%.
The stored pulse rate ranges from 18 to 300 pulses per minute. The stored values are in
increments of 1 pulse per minute in the interval from 18 to 200 pulses per minute, and increments
of 2 pulses per minute in the interval from 201 to 300 pulses per minute.
During the printing of the data, the last data recorded are the first data printed. For example, the
last 4 minutes of data recorded would be the first 4 minutes of printout.

Memory Playback
NOTE: Playing back the data in memory does not clear the data from memory.

Playing Back the Data Stored in Memory

1. With the unit off, press and hold the Advance button while pressing and then releasing
the On/Off button .
2. Release the advance button when 888 888 is displayed on the SpO2 and pulse rate
displays. The clock time currently set in the memory (04 41 for example) appears
briefly in the displays, and then rCL no appears.
3. Data will be automatically played back from the memory. Data are played back at a rate of
20 minutes of collected data per second. A 72-hour recording session (the maximum
memory saved) is played back in approximately 3.5 minutes.
4. After all data are played back, the device should be shut off before collecting new patient
data. The patient information is held in memory as long as the batteries are sufficiently
charged, so if the memory must be cleared, use the memory clear function.

20
Memory Functions

Clearing the Memory

The Memory Clear function allows you to delete all data currently stored in memory.

Choosing Memory Clear Settings

1. Enter Setup mode, and scroll through the settings until CLr is displayed.
2. CLr may be set to no or yES.
• If no is entered in response to CLr (indicating that you do not want to clear the memory),
the setup mode will continue directly to the calendar and clock settings. (Refer to “Clock
and Calendar Settings.”)
• If yES is entered in response to CLr, then dEL will next appear in the SpO2 display, again
with a choice of no or yES. This prompting gives you a second opportunity to avoid
clearing the memory.
Make the CLr selection. Use the Advance button to scroll through the values. Use the On/Off
button to accept a value and move to the next setting.
3. dEL may be set to no or yES.
• If no is entered in response to dEL (indicating that you do not want to clear the memory),
the setup mode will continue directly to the calendar and clock settings. (Refer to
“Choosing Calendar and Clock Settings.”)
• If yES is entered in response to dEL, (confirming that you do want to clear the memory),
then dnE CLr will briefly appear in the displays indicating that the memory is cleared.
After the alarm settings are reviewed, the device will exit setup mode and is ready to begin
normal operation.
Make the dEL selection. Use the Advance button to scroll through the values. Use the On/Off
button to accept a value and move to the next setting.

Choosing Calendar and Clock Settings

NOTE: Setting the month to “00” disables the calendar and clock functions and helps
conserve battery life.

1. After selecting no in the memory clear settings, y will appear in the SpO2 display
indicating the calendar year setting.
2. Make the year, month, day, hour, and minute selections. Use the Advance button to scroll
through the values. Use the On/Off button to accept a value and move to the next setting.
3. Press and release the On/Off button to exit setup mode.
When the time setting sequence is complete, the device exits Setup mode, automatically
displays the alarm settings in effect, and is then ready to begin normal operation.

21
 Communications

Communications
Serial Output
The Model 2500A provides real-time data output capability via the pulse oximeter sensor
connector (a 9-pin Sub-D connector). The pulse oximeter sensor connector pin assignments are
listed below.
Table 5: Pulse Oximeter Sensor Connector Pin Assignments

Pin Number Assignment

1 1-Wire®

2 Infrared Anode, Red Cathode

3 Infrared Cathode, Red Anode

4 Serial Data, TTL Levels

5 Detector Anode

6 Sensor Type

7 Cable Shield (Ground)

8 No Connection

9 Detector Cathode, +5 V

Information from the device, in the real-time mode, is sent in an ASCII serial format at 9600 baud
with 9 data bits, 1 start bit, and 1 stop bit. The data are output at a rate of once per second.

NOTE: The 9th data bit is used for odd parity in memory playback mode. In real-time mode,
it is always set to the mark condition. Therefore the real-time data may be read as 8 data
bits, no parity.

Real-time data may be printed or displayed by devices other than the pulse oximeter. On power
up a header is sent identifying the format and the time and date. Thereafter, the data are sent once
per second in the following format:
SPO2=XXX HR=YYY
where “XXX” represents the SpO2 value, and “YYY” represents the pulse rate. The SpO2 and
pulse rate will be displayed as “---” if there are no data available for the data reading.

Connecting the Device into a Medical System

Incorporating the device into a medical system requires the integrator to identify, analyze, and
evaluate the risks to patient, operators, and third parties. Subsequent changes to the medical
system after device integration could introduce new risks and will require additional analysis.
Changes to the medical system that must be evaluated include:
• Changing the system configuration
• Adding devices to or disconnecting devices from the system

22
Communications

• Updating or upgrading equipment connected to the system

Issues resulting from user-initiated system changes may include corruption or loss of data.

NOTES:
• When using the serial port to connect the device to other equipment, follow each device’s
cleaning instructions.
• Verify all equipment connected to the device is suitable for the patient’s environment.

CAUTION: Failure of a network data coupling (serial cable/connectors/wireless

! connections) will result in loss of data transfer.

23
 Service, Support and Warranty

Service, Support and Warranty

CAUTION: 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.

CAUTION: 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.

The advanced digital circuitry within the Model 2500A requires no periodic maintenance or
calibration. The device’s expected service life is 5 years. Nonin does not recommend field repair
of the Model 2500A. The circuit board in the Model 2500A is a multi-layer board using very narrow
traces. Due to the very small trace size, extreme care must be used when replacing components
to prevent permanent, non-repairable damage to the circuit board. Most components are
surface-mounted and require special hot-air jet soldering and desoldering equipment. After any
repairs are made, the Model 2500A must be tested to ensure correct operation.
For additional technical information, contact Nonin’s Technical Service department at:

Nonin Medical, Inc.

13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA

(800) 356-8874 (USA and Canada)

+1 (763) 553-9968
Fax: +1 (763) 553-7807
E-mail: [email protected]

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: [email protected]

nonin.com

All non-warranty work shall be done according to Nonin standard rates and charges in effect at
the time of delivery to Nonin. All repairs include a complete retest of the Model 2500A using factory
test fixtures.

24
Service, Support and Warranty

Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of three
years from the date of purchase, each Model 2500A Pulse Oximeter exclusive of sensors, cables,
and batteries. (Refer to the individual package inserts for specific warranty information for sensors,
cables, and other accessories.) Nonin shall repair or replace any Model 2500A found to be
defective in accordance with this warranty, free of charge, for which Nonin has been notified by
the purchaser by serial number that there is a defect, provided said notification occurs within the
applicable warranty period. This warranty shall be the sole and exclusive remedy by the purchaser
hereunder for any Model 2500A delivered to the purchaser which is found to be defective in any
manner whether such remedies be in contract, tort or by law.
This warranty excludes cost of delivery to and from Nonin. All repaired units shall be received by
the purchaser at Nonin's place of business. Nonin reserves the right to charge a fee for a warranty
repair request on any device that is found to be within specifications.
The Model 2500A is a precision electronic instrument and must be repaired by knowledgeable and
specially trained Nonin personnel only. Accordingly, any sign or evidence of opening the Model
2500A, field service by non-Nonin personnel, tampering, or any kind of misuse or abuse of the
Model 2500A, shall void the warranty in its entirety.
All non-warranty work shall be done according to Nonin standard rates and charges in effect at the
time of delivery to Nonin.
DISCLAIMER/EXCLUSIVITY OF WARRANTY:
THE EXPRESS WARRANTIES SET FORTH IN THIS MANUAL ARE EXCLUSIVE AND NO
OTHER WARRANTIES OF ANY KIND, WHETHER STATUTORY, WRITTEN, ORAL, OR
IMPLIED INCLUDING WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR
MERCHANTABILITY SHALL APPLY.

25
 Parts and Accessories

Parts and Accessories

For more information about Nonin parts and accessories:
• See the Parts and Accessories List on the Operator’s Manual CD.
• Contact your distributor or Nonin at (800) 356-8874 (USA and Canada),
+1 (763) 553 9968, or +31 (0)13 - 79 99 040 (Europe).
• Visit www.nonin.com
Detailed information regarding specified sensor use (patient population, body/tissue, and
application) can be found in the respective sensor instructions.

WARNING: 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.

WARNING: To avoid patient injury, use only with Nonin-branded PureLight® 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.

26
Troubleshooting

Troubleshooting

Problem Possible Cause Possible Solution

The batteries are depleted. Replace all 4 batteries.

Verify correct battery

The batteries are installed
orientations. Refer to Figure 3:
incorrectly.
The device won’t turn on. Installing Batteries.

A metal contact in the battery

Contact Nonin Technical
compartment is missing or
Service.
damaged.

Verify that the sensor is

A sensor fault exists. The sensor
A dash appears in the left correctly connected to the
may have become dislodged from
digit of the SpO2 display. device and the patient; replace
the device or from the patient.
sensor if the condition persists.

The middle digits display No signal is detected because the

Verify the sensor connections.
dashes in both the SpO2 sensor is not plugged in.
and Pulse Rate displays. A sensor failure. Replace the sensor.

Eliminate or reduce the cause

Excessive motion at the sensor
of the motion artifact or
site may be prohibiting the device
reposition the sensor to a new
from acquiring a consistent pulse
sensor site where motion is not
signal.
present.

The patient may have an Examine the patient: the

The displayed pulse rate arrhythmia resulting in some condition may persist even
does not correlate to the heart beats that do not yield a though both monitors are
pulse rate displayed on pulse quality signal at the sensor functioning properly if the
the ECG monitor. site. patient's arrhythmia persists.

A non-specified sensor is being Replace the sensor with a

used. Nonin-branded sensor.

Examine the patient:

The ECG monitor may not be replace the ECG monitor or
functioning properly. refer to the operator's manual
for the ECG monitor.

An erratic Pulse Rate

Examine the patient: move the
display and/or an amber
device, cables, and sensors as
Pulse Quality display The ESU may be interfering with
far away from the ESU as
during the concurrent use the pulse oximeter performance.
possible or refer to the ESU
of electrosurgical
operator's manual.
equipment (ESU).

27
 Troubleshooting

Problem Possible Cause Possible Solution

The Pulse Quality display Examine the patient: reposition

The quality of the pulse signal at
is blinking amber with sensor or select an alternate
the sensor site is marginal.
each pulse. sensor site.

Low patient pulse strength;

or
the sensor site is poorly perfused; Reposition the sensor on the
or patient.
the sensor is not correctly
positioned.

The sensor is attached too tightly, Reapply the sensor, select an

or tape or other items are alternate sensor site, or
restricting the pulse quality at the remove the restrictive material
sensor site. from the sensor site.

Circulation is reduced due to Allow the sensor and finger,

Unable to obtain a green
excess pressure between the foot, etc., to rest comfortably
blinking Pulse Quality
sensor and a hard surface. on the surface.
display.
Excessive ambient light. Reduce the ambient light.

Excessive patient motion. Reduce the patient motion.

The sensor is applied to a

Remove the nail polish.
polished finger or toe nail.

Interference from:
• arterial catheter
Reduce or eliminate the
• blood pressure cuff
interference.
• electrosurgical procedure
• infusion line

Examine the patient: reposition

An inadequate signal at the
sensor or select an alternate
sensor site.
sensor site.
The Pulse Quality display
Eliminate or reduce the cause
is blinking red and the Excessive motion at the sensor
of the motion artifact or
SpO2 and/or Pulse Rate site may be prohibiting the device
reposition the sensor to a
displays show dashes. from acquiring a consistent pulse
sensor site where motion is not
signal.
present.

A sensor failure. Replace the sensor.

Segments of the SpO2 or Displayed values may not be

Pulse Rate displays are Defective LED displays. reliable; discontinue use of the
missing. device.

28
Troubleshooting

Problem Possible Cause Possible Solution

Turn the device off and on. If

Err E01, E02, E03, or There is a system fault that must
the problem persists, contact
E04 is displayed. be corrected.
Nonin Technical Service.

Disruption in the device Electromagnetic interference Remove the device from the
performance. (EMI). EMI environment.

Turn the device off and on. If

the problem persists or the
Displays and indicators
device does not turn on,
are off, but a continuous There is a system fault that must
replace or recharge the
audible alarm is be corrected.
batteries. If the problem still
sounding.
persists, contact Nonin
Technical Service.

NOTE: If these solutions do not correct the problem with your device, please contact
Nonin Technical Service at (800) 356-8874 (USA and Canada), +1 (763) 553-9968, or
+31 (0)13 - 79 99 040 (Europe).

29
 Technical Information

Technical Information
NOTE: This product complies with ISO 10993-1, Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing.

CAUTION: A functional tester cannot be used to assess the accuracy of a pulse

! oximeter monitor or sensor.

CAUTION: All parts and accessories connected to the serial port of this device must
! be certified according to at least IEC Standard EN 60950 or UL 1950 for data-
processing equipment.

CAUTION: Portable and mobile RF communications equipment can affect medical

! electrical equipment.

Manufacturer’s Declaration
Refer to the following table for specific information regarding this device’s compliance to
IEC 60601-1-2.

Table 6: Electromagnetic Emissions

Emissions Test Compliance Electromagnetic Environment—Guidance

This device is intended for use in the electromagnetic environment specified below. The user of this
device should ensure that it is used in such an environment.
RF Emissions Group 1 This device uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.

RF Emissions Class B This device is suitable for use in all

CISPR 11 establishments, including domestic and those
directly connected to the public low-voltage
Harmonic Emissions N/A power supply network that supplies buildings
IEC 61000-3-2 used for domestic purposes.

Voltage Fluctuations/ N/A

Flicker Emissions
IEC 61000-3-3

30
Technical Information

Table 7: Electromagnetic Immunity

IEC 60601 Electromagnetic

Immunity Test Compliance Level
Test Level Environment—Guidance

This device is intended for use in the electromagnetic environment specified below. The user of this device
should ensure that it is used in such an environment.
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,
Discharge (ESD) ±8 kV air ±8 kV air concrete, or ceramic tile. If
IEC 61000-4-2 floors are covered with synthetic
material, the relative humidity
should be at least 30%.

Electrical Fast ±2 kV for power ±2 kV for power Mains power quality should be
Transient/Burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 ±1 kV for input/ ±1 kV for input/output hospital environment.
output lines lines

Surge ±1 kV differential ±1 kV differential Mains power quality should be

IEC 61000-4-5 mode mode that of a typical commercial or
±2 kV common ±2 kV common mode hospital environment.
mode

Voltage dips, short ±5% UT (>95% dip in ±5% UT (>95% dip in Mains power quality should be
interruptions, and UT) for 0.5 cycle UT) for 0.5 cycle that of a typical commercial or
voltage variations on ±40% UT (60% dip in ±40% UT (60% dip in hospital environment. If the user
power supply input UT) for 5 cycles UT) for 5 cycles of the device requires continued
lines operation during power mains
±70% UT (30% dip in ±70% UT (30% dip in interruptions, it is recommended
IEC 61000-4-11 UT) for 25 cycles UT) for 25 cycles that the device be powered from
<5% UT (>95% dip in <5% UT (>95% dip in an uninterruptible power supply
UT) for 5 sec. UT) for 5 sec. or battery pack.

Power Frequency 3 A/m 3 A/m Power frequency magnetic

(50/60 Hz) Magnetic fields should be at levels
Field characteristic of a typical
IEC 61000-4-8 location in a typical commercial
or hospital environment.

Note: UT is the AC mains voltage before application of the test level.

31
 Technical Information

Table 8: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

IEC 60601 Compliance Electromagnetic Environment—

Immunity Test
Test Level Level Guidance
This device is intended for use in the electromagnetic environment specified below. The user of this
device should ensure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the
device, including cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended Separation Distance

Conducted RF 3 Vrms 3V d = 1.17 P

IEC 61000-4-6 150 kHz to
80 MHz
Radiated RF 3 V/m 3 V/m d = 1.17 P
IEC 61000-4-3 80 MHz to
2.5 GHz d = 2.33 P

Radiated RF per ISO 20 V/m 20 V/m where P is the maximum output power
9919 clause 36 and 80 MHz to rating of the transmitter in watts (W)
ISO 80601-2-61 2.5 GHz according to the transmitter manufacturer
clause 202.6.2.3 and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:

NOTES:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theo-
retically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electro-
magnetic site survey should be considered. If the measured field strength in the location in which the device
is used exceeds the applicable RF compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

32
Technical Information

Table 9: Recommended Separation Distances

This table details the recommended separation distances between portable and mobile RF
communications equipment and this device.
This device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. Users of this device can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communication equipment (transmitters) and the device as
recommended below, according to maximum output power of the communications equipment.

Separation Distance According to Frequency of Transmitter

Rated Maximum Output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Power of Transmitter W d = 1.17 P d = 1.17 P d = 2.33 P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.

NOTES:
• At 80 MHz and 800MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.

33
 Technical Information

Equipment Response Time

If the signal from the sensor is inadequate, the last measured SpO2 and pulse rate values freeze
for 10 seconds and are then replaced with dashes.

SpO2 Values Average Latency

Standard/Fast Averaged SpO2 4 beat exponential 2 beats

Pulse Rate Values Response Latency

Standard/Fast Averaged Pulse Rate 4 beat exponential 2 beats

Equipment Delays Delay

Display Update Delay 1.5 seconds
Alarm Signal Generation Delay 0 seconds

Example - SpO2 Exponential Averaging

SpO2 decreases 0.75% per second (7.5% over 10 seconds)
Pulse Rate = 75 BPM Specific to this example:

SaO2 Reference 4 Beat Average

100

95

90

85
SpO2

80

75

70

65

60
0.0

8.0

16.0

24.0

32.0

40.0

48.0

56.0

64.0

72.0

80.0

Time in seconds

• The response of the 4-beat average is 1.5 seconds.

34
Technical Information

Testing Summary
SpO2 accuracy, and low perfusion testing were conducted by Nonin Medical, Inc., as described
below:

SpO2 Accuracy Testing

During motion and no-motion conditions at an independent research laboratory, SpO2 accuracy
testing is conducted during induced hypoxia studies on healthy, male and female, non-smoking,
light- to dark-skinned subjects that are 18 years of age and older. The measured arterial
hemoglobin saturation value (SpO2) of the sensors is compared to arterial hemoglobin oxygen
(SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the
sensors in comparison to the co-oximeter samples measured over the SpO2 range of 70 - 100%.
Accuracy data is calculated using the root-mean-squared (Arms value) for all subjects, per
ISO 80601-2-61, Medical Electrical Equipment—Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use.

Pulse Rate Motion Testing

This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a
pulse oximeter tester. This test determines whether the oximeter meets the criteria of ISO 80601-
2-61 for pulse rate during simulated movement, tremor, and spike motions.

Low Perfusion Testing

This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude
settings at various SpO2 levels for the oximeter to read. The oximeter must maintain accuracy in
accordance with ISO 80601-2-61 for heart rate and SpO2 at the lowest obtainable pulse amplitude
(0.3% modulation).

Principles of Operation
Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue
and detects the fluctuating signals caused by arterial pulses. Well-oxygenated blood is bright red,
while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen
saturation of arterial hemoglobin (SpO2) from this color difference by measuring the ratio of
absorbed red and infrared light as volume fluctuates with each pulse.

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 Technical Information

Specifications
Oxygen Saturation Display Range 0 to 100% SpO2
Pulse Rate Display Range 18 to 321 beats per minute (BPM)
Accuracy – Sensors Declared accuracy data for compatible sensors can be found
in Nonin’s Sensor Accuracy document.
Measurement Wavelengths and Output Power*
Red: 660 nanometers @ 0.8 mW maximum avg.
Infrared: 910 nanometers @ 1.2 mW maximum avg.
Alarm Volume: High: 69 dBA
Low: 52 dBA
Informational Tone Volume: High: 65 dBA
Low: 45 dBA
Indicators

Pulse Quality Display: LED, tricolor

Numeric Displays: 3-digit 7-segment LEDs, red
Low Battery Indicator: LED, amber
Alarm Bar: LED, bicolor
Alarm Silence Indicator: LED, amber
Temperature (Operating) -20 to +50 C (-4 to +122 F)
Temperature (Storage/Transportation): -40 to +70 C (-40 to +158 F)
Humidity (Operating) 10 to 95% noncondensing
Humidity (Storage/Transportation): 10 to 95% noncondensing
Altitude (Operating) Up to 12,000 meters (40,000 feet)
Altitude (Hyperbaric Pressure): Up to 4 atmospheres
Power Requirements Four 1.5V AA-size alkaline batteries (60 hours typical
operation) or NiMH rechargeable battery pack (40 hours
typical operation)
Dimensions 13.8 cm H x 7.0 cm W x 3.2 cm D
(5.4 in H x 2.8 in W x 1.3 in D)
Weight 213 g (7.5 oz) (with alkaline batteries) 233 g (8.2 oz) (with
NiMH rechargeable battery pack)
Classifications per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL 60601-1
Type of Protection: Internally powered (on battery power)
Degree of Protection: Type BF-Applied Part
Mode of Operation: Continuous
Enclosure Degree of Ingress Protection IP32
* This information is especially useful for clinicians performing photodynamic therapy.

This device is not made with natural rubber latex.

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