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Operator’s Manual
01230123
Model 2500 PalmSAT
Pulse Oximeter
®
English
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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
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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
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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
2
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.
2
measurement. Verify that
2
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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
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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
2
with dashes, indicating that readings are not possible.
data. It may blink green, amber or red.
2
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
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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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Using the PalmSAT Pulse Oximeter
5822-000-05
UL 60601-1
US PATENT # Re.33,643
PULSE OXIMETER
MODEL 2500
PLYMOUTH, MN USA
NONIN MEDICAL, INC.
4 X 1.5V AA
IEC LR6
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IP32
30EM
See Accompanying
Documents
Battery
Cover
Latch
Battery
Cover
The Model 2500 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 SpO
not received, the SpO
and/or pulse rate numerical values will be replaced by dashes. Low and
2
value on the LED display. When adequate pulse signals are
2
critically low battery conditions will be indicated by the Low Battery indicator.
Figure 2: Rear View
Unpacking the Model 2500
The Model 2500 complete system includes the following items:
• 1 Model 2500 Pulse Oximeter
• 1 Model 2500 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.
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Using the PalmSAT Pulse Oximeter
Installing and Using the Batteries
The Model 2500 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.
!
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.
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.
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Using the PalmSAT Pulse Oximeter
Battery
Orientation
AA-size
Alkaline
Batteries
Battery Pack
Figure 3: Installing Batteries
Important Notes about Battery Use
Four AA alkaline batteries provide the device with approximately 80 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.
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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 o n the device by pressing and releasing the On/Off button on the front of the unit.
• Turn o ff 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 2500 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. 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 SpO
• the amber Low Battery LED turns on steadily for a few seconds.
and Pulse Rate displays.
2
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Using the PalmSAT Pulse Oximeter
• the Pulse Quality display turns red for 1 second, then green for 1 second, then shuts off.
• 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 digit; Memory revision “n” “n” (for m) + 3 digits.
• (two dashes) appear in the displays until a valid pulse signal is detected.
NOTE: 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 SpO
displays are displaying readings and
2
• 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 SpO
and Pulse Rate displays will display a single
2
dash until a valid pulse signal is detected.
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Detailed Operation
Detailed Operation
All functions of the Model 2500 are controlled by the On/Off and Advance buttons located
on the front of the unit.
Setup Mode
Setup mode is used to set:
1. memory clear function,
2. calendar and clock, and
3. memory playback function.
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 SpO
Rate displays. The clock time currently set in the memory, 04 41 for example,
appears briefly in the displays, and then CLr no appears.
and Pulse
2
Making Selections in Setup Mode
1. When entering Setup mode, CLr no is displayed. (This indicates the memory clear
setting is 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, and is then ready to begin
normal operation.
Table 2: Adjustable Parameters and Settings
Setting
Memory Clear
Delete (confirm clear) dEL yes or no no
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a
Appears in SpO
Display
CLr yes or no no
Range of Values Appears in
2
Pulse Rate Display
Default
Value
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Detailed Operation
Table 2: Adjustable Parameters and Settings (Continued)
Setting
Appears in SpO
Display
Range of Values Appears in
2
Pulse Rate Display
Default
Value
Year y00 - 99 07
Month nn 00 - 12 00
Day d01 - 31 00
Hour h00 - 23 00
Minute nn 00 - 59 00
a. Choosing “yes” for both the CLr and dEL settings (the memory clear function) will clear the memory and exit
setup mode.
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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 Oxitest
!
!
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.
Plus7
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.
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Visual Indicators
Visual Indicators
The intended operator’s position for correctly perceiving a visual signal and its priority is 1 meter
(3.3 feet).
The following table describes visual indicators and conditions.
Condition Visible Indication
Pulse Waveform Signal is
inadequate
Sensor fault (i.e., sensor
disconnect, failure, or
incompatibility with the
monitor)
Inadequate Signal (Sensor
misalignment, ambient light,
nail polish/artificial nails, etc.)
Inadequate SpO
or pulse rate
2
data (excessive motion or
erratic heart rate, etc.) more
than 20 seconds
Pulse rate data not updated
for more than 30 seconds
• Pulse Quality LED blinks red
•SpO
and heart rate LEDs display dashes after
2
10 seconds
• Pulse Quality LED blinks
• Dash (-) appears in the leftmost position of the SpO
display
•SpO
and Heart Rate numeric displays freeze for
2
10 seconds
• Pulse Quality LED is blank
• Dash (-) appears in the leftmost position of the SpO
display
•SpO
and Heart Rate numeric displays freeze for
2
10 seconds
• Dash (-) appears in SpO
and pulse rate displays
2
• Pulse rate numeric display becomes dashes
2
2
Low Battery
Critically Low Battery
• Low Battery indicator is solid amber LED. No other
displays are affected.
• Critically Low Battery indicator is flashing
•SpO
and pulse rate LEDs are blank
2
• Pulse Quality display is solid red or amber
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Memory Functions
Memory Functions
Each time the Model 2500 is turned on (except during Setup mode), data are automatically
collected in memory. The device can collect and store up to 72 hours of SpO
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 SpO
rate are sampled and stored every 4 seconds.
and pulse rate
2
and pulse
2
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.
The last data recorded will be the first data printed. For example, the last 4 minutes of data
recorded would be the first 4 minutes of printout.
Memory Download
NOTE: Downloading the data in memory does not clear the memory.
Downloading 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 SpO
rate displays. The clock time currently set in the memory (04 41 for example)
appears briefly in the displays, and then CLr no appears.
3. Data will be automatically downloaded from memory. Data is downloaded at a rate of
20 minutes of collected data per second. A 72-hour recording session (the maximum
memory saved) is downloaded in approximately 3.5 minutes.
4. After downloading is complete, the device should be shut off before collecting new
patient data.
5. The patient data is held in memory as long as the batteries are sufficiently charged.
(See “Clearing the Memory” section.) To clear memory, use the memory clear
function.
and pulse
2
16
Page 23
Memory Functions
Clearing the Memory
The Memory Clear function allows you to delete all data currently stored in memory.
Clear Memory Mode
1. Enter Setup mode; CLr no will be 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 SpO
with a choice of no or yES. This prompt gives you a second opportunity to avoid clearing
the memory.
• Select CLr; 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. The
device will exit setup mode and is ready to begin normal operation.
• Select dEL; use the Advance button to scroll through the values.
• Use the On/Off button to accept a value and move to the next setting.
display, again
2
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 clear memory mode, y will appear in the SpO
2. Select the year, month, day, hour, and minute by scrolling the Advance button 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 calender and clock settings are complete, the device exits Setup mode, and is then
ready to begin normal operation.
display.
2
17
Page 24
Communications
Communications
Serial Output
The Model 2500 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 3: Pulse Oximeter Sensor Connector Pin Assignments
Pin Number Assignment
11-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 download. In real-time mode, it is
always set to the mark condition. Therefore, 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 date and time. Thereafter, the data are sent once
per second in the following format:
SPO2=XXX HR=YYY
where “XXX” represents the SpO
value, and “YYY” represents the pulse rate. The SpO2 and
2
pulse rate will be displayed as “---” if there are no data available for the data reading.
18
Page 25
Communications
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
• 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.
19
Page 26
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 2500 requires no periodic maintenance or
calibration. The device’s expected service life is 5 years. Nonin does not recommend field repair
of the Model 2500. The circuit board in the Model 2500 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 2500 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: technicalservice@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: technicalserviceintl@nonin.com
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 2500 using factory
test fixtures.
20
Page 27
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 2500 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 2500 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 2500 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 2500 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
2500, field service by non-Nonin personnel, tampering, or any kind of misuse or abuse of the
Model 2500, 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.
21
Page 28
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 specific sensor use (patient population, body/tissue, and
application) can be found in the respective sensor Instructions for Use.
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
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.
®
pulse
22
Page 29
Troubleshooting
Troubleshooting
Problem Possible Cause Possible Solution
The device won’t turn on.
The batteries are depleted. Replace all 4 batteries.
Verify battery orientation,
The batteries are installed
incorrectly.
illustrated inside the battery
compartment or in Figure 3:
Installing Batteries section of
this operator’s manual.
A dash appears in the
leftmost position of the
SpO
display.
2
Dashes are displayed in
both the SpO
and Pulse
2
Rate displays.
The displayed pulse rate
does not correlate to the
pulse rate displayed on
the ECG monitor.
A metal contact in the battery
compartment is missing or
damaged.
A sensor fault exists
(disconnect, failure,
misalignment, or incompatibility
with the monitor).
No signal is detected because
the sensor is not plugged in.
Contact Nonin Technical
Service.
Verify that the sensor is
correctly connected to the
device and the patient; replace
sensor if the condition persists.
Verify the sensor connections.
Sensor failure. Replace the sensor.
Excessive motion at the sensor
site may be prohibiting the
device from detecting a
consistent pulse signal.
Eliminate or reduce the cause
of the motion or
reposition the
sensor to a new sensor site.
The patient may have an
arrhythmia resulting in some
heart beats that do not detect a
Assess the patient.
pulse quality signal at the
sensor site.
An erratic Pulse Rate or
an amber Pulse Quality
display during the use
with electrosurgical unit
(ESU).
A non-compatible sensor is
being used.
The ECG monitor may not be
functioning properly.
The ESU may be interfering with
the pulse oximeter performance.
Replace the sensor with a
Nonin-branded PureLight
sensor.
Assess the patient.
Assess the patient. Move the
device, cables, and sensors as
far away from the ESU as
possible.
23
Page 30
Troubleshooting
Problem Possible Cause Possible Solution
The Pulse Quality
display is blinking amber
with each pulse.
Numeric display
segments are missing.
Degradation of device
performance.
Pulse Quality display
does not blink green.
The quality of the pulse signal at
the sensor site is inadequate.
Assess the patient. Reposition
sensor or
select an alternate
sensor site.
Defective LEDs. Discontinue use of the device.
Electromagnetic interference
(EMI).
Remove the device from the
EMI environment.
Inadequate pulse signal
or
the sensor is not correctly
Reposition the sensor.
positioned.
Remove the restriction to
The sensor is restricting blood
circulation at the sensor site.
increase blood circulation at
the sensor site or
relocate the
sensor.
Excessive ambient light. Reduce ambient light.
Excessive patient motion. Reduce patient motion.
The patient is wearing nail
polish or artificial nails.
Remove nail polish or artificial
nails.
Performance degradation from:
• arterial catheter
• blood pressure cuff
• infusion line
Reduce or eliminate the
source.
Assess the patient. Reposition
The Pulse Quality
Inadequate signal at sensor site.
sensor or
select an alternate
sensor site.
display is blinking red
and the SpO
and/or
2
Pulse Rate displays are
dashes.
Inadequate pulse signal due to
excessive motion.
Reduce patient motion.
Reposition or
relocate the
sensor.
Sensor failure. Replace the sensor.
Note: If these solutions do not correct the problem with your device, please contact
Nonin Technical Service at (800) 356-8874 (USA and Canada) or +1 (763) 553-9968, or
+31 (0)13 - 79 99 040 (Europe).
24
Page 31
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 dataprocessing 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 4: 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
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker
Emissions
IEC 61000-3-3
Group 1 This device uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
Class B This device is suitable for use in all
establishments, including domestic and those
directly connected to the public low-voltage power
N/A
N/A
supply network that supplies buildings used for
domestic purposes.
25
Page 32
Table 5: Electromagnetic Immunity
Technical Information
Immunity Test
IEC 60601 Test
Level
Compliance Level
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.
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete, or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
±5% U
U
±40% U
U
±70% U
U
<5% U
U
(>95% dip in
T
) for 0.5 cycle
T
(60% dip in
T
) for 5 cycles
T
(30% dip in
T
) for 25 cycles
T
(>95% dip in
T
) for 5 sec.
T
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
±5% U
U
±40% U
U
±70% U
U
<5% U
U
(>95% dip in
T
) for 0.5 cycle
T
(60% dip in
T
) for 5 cycles
T
(30% dip in
T
) for 25 cycles
T
(>95% dip in
T
) for 5 sec.
T
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the device requires continued
operation during power mains
interruptions, it is recommended
that the device be powered from
an uninterruptible power supply
or battery pack.
Power Frequency (50/
60 Hz) Magnetic Field
IEC 61000-4-8
Note: U
is the AC mains voltage before application of the test level.
T
26
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
Page 33
Technical Information
d1.17P=
d1.17P=
d2.33P=
Table 6: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
Immunity Test
IEC 60601 Test
Level
Compliance
Level
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.
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
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Radiated RF per
ISO 9919 clause 36
and ISO 80601-2-61
clause 202.6.2.3
3 V
rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
20 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
20 V/m where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
a
survey
, should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
b
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 theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic 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.
27
Page 34
Technical Information
d1.17P=
d1.17P=
d2.33P=
Table 7: 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
Power of Transmitter W
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
11.21.22.3
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.
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
28
Page 35
Technical Information
60
65
70
75
80
85
90
95
100
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
SpO 2
SaO2 Ref er enc e 4 Beat Average
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.
Values
SpO
2
Average Latency
Standard/Fast Averaged SpO
2
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
Example - SpO2 Exponential Averaging
SpO2 decreases 0.75% per second (7.5% over 10 seconds)
Pulse Rate = 75 BPM Specific to this example:
• The response of the 4-beat average is 1.5 seconds.
29
Page 36
Technical Information
Testing Summary
SpO2 accuracy, and low perfusion testing was 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 (SpO
(SaO
sensors in comparison to the co-oximeter samples measured over the SpO
Accuracy data is calculated using the root-mean-squared (A
ISO 80601-2-61, Medical Electrical Equipment—Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use.
) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the
2
Pulse Rate Motion Testing
) of the sensors is compared to arterial hemoglobin oxygen
2
range of 70 - 100%.
2
value) for all subjects, per
rms
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 806012-61 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 SpO
accordance with ISO 80601-2-61 for heart rate and SpO
(0.3% modulation).
levels for the oximeter to read. The oximeter must maintain accuracy in
2
at the lowest obtainable pulse amplitude
2
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 (SpO
absorbed red and infrared light as volume fluctuates with each pulse.
) from this color difference by measuring the ratio of
2
30
Page 37
Technical Information
Specifications
Oxygen Saturation Display Range 0 to 100% SpO
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 max. avg.
Infrared: 910 nanometers @ 1.2 mW max. avg.
Indicators
Pulse Quality Display: LED, tricolor
Numeric Displays: 3-digit 7-segment LEDs, red
Low Battery 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
2
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 (80 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 210 g (7.4 oz) (with alkaline batteries)
230 g (8.1 oz) (with NiMH rechargeable battery pack)
Classifications per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL60601-1
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.
31
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