Nonin 8500 User manual

Operator’s Manual
Model 8500
Handheld Pulse Oximeter
English

.
Nonin®reserves the right to make changes and improvements to this manual and the products it
describes at any time, without notice or obligation.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA
[phone]
[phone] (USA and Canada)
Fax: [phone]
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
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
References to “Nonin” in this manual shall imply Nonin Medical, Inc. Nonin, PureLight and
nVISION are registered trademarks or trademarks of Nonin Medical, Inc. Microsoft®and
Windows®are registered trademarks of Microsoft Corporation.
© 2019 Nonin Medical, Inc.
6130-001-05
Follow Instructions for Use.
EC
REP

i
Contents
Indications for Use ........................................................................................ 1
Warnings ................................................................................................................1
Cautions .................................................................................................................2
Guide to Symbols.......................................................................................... 4
Displays and Indicators ................................................................................ 6
SpO2Display..........................................................................................................6
Pulse Rate Display.................................................................................................6
Pulse Quality Indicator............................................................................................6
Low Battery Indicator..............................................................................................6
Sensor Fault or Inadequate Signal Display............................................................6
Using the 8500 Pulse Oximeter.................................................................... 8
Unpacking the Model 8500.....................................................................................8
Installing and Using the Batteries...........................................................................8
Important Notes about Battery Use........................................................................9
Connecting the Sensor.........................................................................................10
Turn On/Off...........................................................................................................10
Startup Self-Test...................................................................................................11
Detailed Operation....................................................................................... 12
Setup Mode..........................................................................................................12
Entering Setup Mode........................................................................................12
Care and Maintenance................................................................................. 13
Visual Indicators.......................................................................................... 14
Communications.......................................................................................... 15
Serial Output.........................................................................................................15
Connecting the Device into a Medical System.....................................................16
Service, Support and Warranty.................................................................. 17
Warranty...............................................................................................................18
Parts and Accessories................................................................................ 19
Troubleshooting .......................................................................................... 20
Technical Information ................................................................................. 22
Manufacturer’s Declaration...................................................................................22
Essential Performance......................................................................................22
Equipment Response Time..................................................................................24
Testing Summary .................................................................................................25
SpO2Accuracy Testing.....................................................................................25
Pulse Rate Motion Testing................................................................................25
Low Perfusion Testing ......................................................................................25
Principles of Operation.........................................................................................25

ii
Contents (Continued)
Specifications........................................................................................................26

iii
Figures
Figure 1. Front View................................................................................................... 7
Figure 2. Installing Batteries in the 8500.................................................................... 9
Figure 3. Connecting a Sensor................................................................................. 10

iv
Tables
Table 1. Labeling Symbols......................................................................................... 4
Table 2. Electromagnetic Immunity.......................................................................... 22
Table 3. Electromagnetic Immunity.......................................................................... 23
Table 4. Not Applicable............................................................................................ 23

1
Indications for Use
Indications for Use
Nonin®Model 8500 Handheld Pulse Oximeter is indicated for use in measuring and displaying
functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and
neonatal patients in hospitals, ambulatory, home and EMS environments. Model 8500 is intended for
continuous monitoring and/or spot-checking of patients when attended by a healthcare professional.
Warnings
Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses.
Do not use this device in an MR environment.
This device is not defibrillation proof per IEC 60601-1.
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.
Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient
sensitivity to the sensor may vary due to medical status or skin condition.
Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
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.
As with all medical equipment, carefully route patient cabling to reduce the possibility of 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, and cables 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 SpO2measurement. Verify that nothing is
hindering the pulse measurement before relying on the SpO2measurement.
Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
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.
Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

2
Indications for Use
Cautions
Before use, carefully read the Instructions for Use provided with the sensors.
When mounting the monitor to a mobile pole, mounting the monitor higher than 1.5 meters (5 feet) or mounting more than
2 kilograms (4.5 pounds) of equipment onto the pole may result in tipping, damage to the equipment, or injury.
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.
Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the
same time as this may cause the batteries to leak.
Use only Nonin-specified battery types with this device.
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.

3
Indications for Use
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:
When using the monitor in the home, avoid exposing the monitor to lint and dust.
When using the monitor around small children and pets, avoid leaving the monitor unattended. Cables pose a risk of injury,
including strangulation.
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 Standard
EN 60950, IEC 62368-1, 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.
Failure of a network data coupling (serial cable/connectors) will result in loss of data transfer.
Cautions (Continued)
- excessive ambient light
- excessive motion
- electrosurgical interference
- bloodflowrestrictors(arterialcatheters,bloodpressure
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.
- residue (e.g., dried blood, dirt, grease, oil) in the light
path

4
Guide to Symbols
Guide to Symbols
This table describes the symbols that are found on the Model 8500 and in this manual.
Table 1: Labeling Symbols
Symbol Description
CAUTION!
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 medical
devices.
SN Serial Number (located on the back cover).
IP33 Protected against spraying water and against access to hazardous parts with a tool, per
IEC 60529.
Indicates separate collection for electrical and electronic equipment (WEEE).
Authorized Representative in the European Community.
Manufacturer
Catalogue number
Quantity
Date of manufacture
Country of manufacture
Storage/shipping temperature range
RoHS compliant (China)
Federal law (USA) restricts this device to sale by or on the order of a licensed
practitioner.
SpO2%SpO2Display
!
EC
REP
REF
REF
QTY
QTY
US

5
Guide to Symbols
Pulse Rate Display
Pulse Quality Indicator
No Alarms
Front Panel Buttons
ON
OFF
Advance/Dimmer Button
Table 1: Labeling Symbols (Continued)
Symbol Description
|
Ø

6
Displays and Indicators
Displays and Indicators
SpO2Display
The SpO2display is 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 identified by the symbol. This 3-digit LED display shows the pulse rate
in pulses per minute.
Pulse Quality Indicator
The Pulse Quality Indicator display (identified by the symbol) is a tricolor LED that blinks once for
each detected pulse. The color of the Pulse Quality indicator changes with the pulse strength signal,
as described below.
•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, SpO2and
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
When battery capacity is low,the display will blink once each second. If the batteries are not replaced,
they will reach critically low capacity and the display will blink dashes. The Pulse Quality LED will blink
red or amber, not green. After 10 minutes of critically low battery capacity, the display will go blank.
Sensor Fault or Inadequate Signal Display
If the device determines that a sensor fault or inadequate signal condition 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 SpO2display. The readings that are
displayed will freeze 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 SpO2and the Pulse Rate
displays.
When the sensor fault or the inadequate signal is corrected, the SpO2and pulse rate displays will
return to normal operation.


7
Displays and Indicators
Figure 1: Front View
Off Button
On Button
Pulse Rate
Pulse Quality
Indicator
% Oxygen
Saturation
Advance/
Dimmer Button

8
Using the 8500 Pulse Oximeter
Using the 8500 Pulse Oximeter
Unpacking the Model 8500
The Model 8500 system includes the following items:
• 1 Model 8500 Pulse Oximeter
• 1 Model 8500 Operator’s Manual on CD
• 1 Nonin 8000AA Pulse Oximeter Sensor
• 6 AA-Size Alkaline Batteries
Confirm that the items listed are included 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.
Installing and Using the Batteries
The Model 8500 is powered by 6 AA-size alkaline batteries.
1. Press the battery cover latch, and remove the battery cover on the back of the device.
2. Insert six new AA-size alkaline batteries. Insert the batteries as indicated inside the battery
compartment. Proper battery positioning is essential for correct operation.
3. Replace the battery cover and turn the device on. If the device does not turn on, see
“Troubleshooting.”
WARNING: Before changing the batteries, make sure the device is off and the sensor
is not applied to a digit.
CAUTION: Use only Nonin-specified battery types with this device.
CAUTION: Always replace the batteries with fully charged batteries. Do not use fully
charged and partially charged batteries at the same time as this may cause batteries
to leak.
!
!

9
Using the 8500 Pulse Oximeter
Figure 2: Installing Batteries in the 8500
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.
.
Important Notes about Battery Use
• Six AA alkaline batteries provide the device with approximately 100 hours of continuous operation.
• Display brightness can affect battery life; the lower settings will conserve battery life.
•Clock/calendar settings can 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.
• Ifthe clock/calendaris not set when theunit 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.
WARNING: The device turns off after approximately 10 minutes when at critically low
battery capacity.
CAUTION: Replace the batteries as soon as possible after a low battery indication.
Always replace the batteries with fully charged batteries. Do not use fully charged
and partially charged batteries at the same time. This may cause the batteries to leak.
CAUTION: Remove the batteries if the device will be stored for more than 1 month.
!
!

10
Using the 8500 Pulse Oximeter
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
Instructions for Use.
Figure 3: Connecting a Sensor
Turn On/Off
•Turn on the device by pressing the ON ( |) button.
•Turn off the device by pressing the OFF (Ø) button.
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.
TheAdvance/Dimmerbuttoncontrols thebrightnessofthedigitaldisplays.When turned on, the digital
display defaults to the maximum brightness. Pressing the Advance/Dimmer button will decrease the
brightness to the lowest setting, and each subsequent press will increase the brightness through 8
different settings. Lower brightness settings will conserve battery life.
NOTE: Reducing the LED display brightness can extend battery life up to 60%.

11
Using the 8500 Pulse Oximeter
Startup Self-Test
When the device is turned on, the device 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 SpO2and Pulse Rate displays.
• the Pulse Quality display turns red for 1 second, then green for 1 second, then shuts off.
• the clock time currently (in hours and minutes, 04 41 for example) appears briefly in the displays.
• the software revision number (display in the following order): Main revision “r” + 3 numbers: “n” “n”
and “no”.
•(-) a dash appears for Model 8500 in the displays until a valid pulse signal is detected.
Apply the pulse oximeter sensor to the patient’s finger; ensure the system is obtaining an adequate
pulse signal by verifying:
• the pulse oximeter sensor is properly positioned
• the Pulse Quality indicator is blinking green
• the Pulse Rate and SpO2readings are displayed
• the Pulse Quality indicator is blinking in time with the pulse rate for at least 10 seconds
If the Pulse Quality indicator is blinking red or amber or is blinking inconsistently, repositionthe sensor
or replace the sensor.
The SpO2 and Pulse Rate will display a single dash until a pulse signal is detected.

12
Detailed Operation
Detailed Operation
Setup Mode
Setup mode is used to set the calendar and clock.
In Setup mode, the Advance/Dimmer button and the ON ( |) button are used to make all selections.
NOTE: Setting the month to “ 00 ” disables the calendar function and conserves battery life.
Entering Setup Mode
1. With the device off, press and hold theAdvance/Dimmer button while pressing and then
releasing the ON ( |) button; the month and year will appear.
2. Release the Advance/Dimmer button when 888 888 appears in the SpO2and Pulse Rate
displays. The current time and year appear briefly in the displays. To view the other settings,
press and release the ON ( |) button until all settings are reviewed. To change current
settings, press the Advance/Dimmer button until the calendar or clock entry to be changed
appears in the display. Dashes appear in the SpO2and Pulse Rate displays when Set-Up is
complete. The device is ready for use.
To review settings:
•Press and release the ON ( | ) button until all settings are reviewed.
To change settings when set-up mode is entered:
• The year y07 (or user-set year) automatically appears in the display;
•Press the ON ( | ) button to advance the calendar/clock options;
•Set each calendar or clock option by pressing the Advance/Dimmer button until the correct value is
displayed;
•Press the ON ( | ) button to go to the next calendar/clock option;
•Repeat until all values are set.
Dashes appear in the SpO2and Pulse Rate displays when Set-up is complete. The device is ready
for use.
See the table below for display sequence, appearance, and range.
Sequence SpO2Display Range
Year y00 - 99
Month nn 00 - 12
Day d01 - 31
Hours h00 - 23
Minutes nn 00 - 59

13
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.
Clean the device with a soft cloth dampened with isopropyl alcohol or a mild detergent. 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.
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.
!
!

14
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 conditions and visual indicators.
Condition Visual Indication
Pulse Waveform Signal is
inadequate • Pulse Quality LED blinks red
Sensor Fault (i.e., sensor
disconnect, failure, or
incompatibility with the monitor)
• Pulse Quality LED blank
•Dash (-) appears in the leftmost position of the SpO2
display
•SpO
2and Pulse Rate numeric displays freeze for
10 seconds
• After 10 seconds a dash (-) replaces the SpO2and
Pulse Rate numeric displays.
Inadequate Signal (sensor
misalignment, ambient light, nail
polish/artificial nails, etc.)
• Pulse Quality LED blinks
•Dash (-) appears in the leftmost position of the SpO2
display
•SpO
2and Pulse Rate numeric displays freeze for
10 seconds
• After 10 seconds a dash (-) replaces the SpO2and
Pulse Rate numeric displays.
Inadequate SpO2or pulse rate
data (excessive motion or erratic
heart rate, etc.) more than
20 seconds
•Dash (-) appears in SpO2and pulse rate displays
Pulse rate data not updated for
more than 30 seconds • Pulse rate numeric display becomes dashes
Low Battery • SpO2and Pulse Rate displays blink.
Critically Low Battery • SpO2and pulse rate displays are blinking dashes
• Pulse Quality LED is solid red or amber