Nonin 8500 User manual

Operator’s Manual
Models 8500 & 8500M
Handheld Pulse Oximeters
English

i
About the Manual
There are many contraindications, warnings, and cautions throughout this
manual. Read them carefully; they are important to the use of the
product.
The information in this manual has been carefully checked and is believed
to be accurate. In the interest of continued product development,
NONIN reserves the right to make changes and improvements to this
manual and the products it describes at any time, without notice or
obligation.
CAUTION! Federal law (USA) restricts this device to sale by or on the
order of a physician.
CAUTION! Read this manually carefully before using the Model 8500.
Nonin Medical, Inc.
2605 Fernbrook Lane North
Plymouth, MN 55447-4755 USA
[phone]
[phone] (USA and Canada)
Fax [phone]
E-mail: [email protected]
www.nonin.com
Authorized EC Representative:
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
References to “NONIN” in this manual shall imply Nonin Medical, Inc.
NONIN, nVISION, Flexi-Form, and FlexiWrap are registered trademarks or trademarks
of Nonin Medical, Inc.
References to “8500” in this manual imply Models 8500 and 8500M.
© 2002 Nonin Medical, Inc.

ii
Table of Contents
Precautions for Use ....................................................................1
Unpacking the Model 8500 ........................................................3
Introduction................................................................................4
Indications for Use ..................................................................................... 4
General Description ................................................................................... 4
Basic Operation..........................................................................5
Installing Batteries....................................................................................... 5
Connecting Sensors .................................................................................... 7
Features .................................................................................... 10
Controls.................................................................................................... 10
Displays.................................................................................................... 15
Printer/Serial Output............................................................................. 17
Memory Option (8500M Only)............................................................ 18
Specifications............................................................................20
Service....................................................................................... 21
Warranty ...................................................................................22
Accessories ...............................................................................23
Troubleshooting Guide ............................................................24
Guide to Symbols
Attention: See instructions for use.
Type BF Applied Part
(Patient isolation from electric shock)
Canadian Standards Association
UL Underwriters Laboratories
CE Marking indicating conformance to EC
directive No. 93/42/EEC concerning medical
devices

1
Precautions for Use
Contraindications
• Do not use the 8500 in an MRI environment.
• Do not use the 8500 in a situation where alarms are required. The
8500 has no alarms.
Warnings
• Explosion Hazard. Do not use the 8500 in an explosive atmosphere.
• The 8500 is intended only as an adjunct in patient assessment. It
must be used in conjunction with other methods of assessing clinical
signs and symptoms.
• Use only NONIN-manufactured pulse oximeter sensors. These
sensors are manufactured to meet the accuracy specifications for
NONIN Pulse Oximeters. Using other manufacturers’ sensors may
cause improper pulse oximeter performance.
• As with all medical devices, carefully route patient cabling to reduce
the possibility of patient entanglement or strangulation.
• Check the application site frequently to determine the positioning of
the sensor and the circulation and skin sensitivity of the patient.
Each patient’s sensitivity to NONIN sensors might vary, depending
upon medical status or skin condition.
• Discontinue use of adhesive tape strips if the patient exhibits an
allergic reaction to the adhesive material.
• Do not stretch the adhesive tape while applying the sensor. This may
cause inaccurate readings or skin blisters.
• General operation of the 8500 might be affected by the presence of
an electrosurgical unit (ESU).
• Do not use a damaged sensor.
Cautions
• Federal law (USA) restricts this device to sale by or on the order of a
physician.
• Read this manual carefully before using the 8500.
• Before use, carefully read the package insert provided with the
sensor(s).
• The 8500 is intended for spot-checking or monitoring by a health
care professional. Because the 8500 has no audible alarms,
international labeling requirements dictate that it be labeled "Not for
continuous monitoring."
• The 8500 pulse oximeter is not an apnea monitor.

2
• Verify that all visible indicators illuminate during the startup
(initialization) sequence. If any indicator is not lit, do not use the
8500. Contact NONIN Customer Support for repair or replacement.
• The 8500 must be able to measure the pulse properly in order to
obtain an accurate SpO2 measurement. Verify that nothing is
hindering the pulse measurement before relying on the SpO2
measurement.
• The 8500 might not work on all patients. If you are unable to achieve
stable readings, discontinue use.
• The 8500 might misinterpret motion as good pulse quality. Minimize
patient motion as much as possible.
• The 8500 is designed to determine the percentage of arterial oxygen
saturation of functional hemoglobin. Significant levels of
dysfunctional hemoglobin may affect the accuracy of the
measurement.
• Cardiogreen and other intravascular dyes, depending on the
concentration, might affect the accuracy of the SpO2 measurement.
• Ear Clip and Reflectance pulse oximeter 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 immerse the 8500 or NONIN sensors in liquid.
• Do not use caustic or abrasive cleaning agents on the 8500 or on the
sensors.
• The 8500 must be repaired only by trained NONIN personnel.
• Do not use different types of batteries or mix fully- and partially-
charged batteries at the same time.; battery leakage might result.
• Do not remove any covers (except the battery cover) when replacing
batteries.
• Follow local ordinances and recycling instructions regarding disposal
or recycling of the device and device components, including batteries.
Batteries might leak or explode if used or disposed of improperly.
• Remove the batteries to avoid the risk of leakage if the 8500 will be
stored for more than one month.
• This equipment complies with International Standard EN 60601-1-
2:1993 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 (for example, cellular phones,
electrical appliances), it is possible that high levels of such
interference due to close proximity or strength of a source might
result in disruption of performance of this device.

3
Unpacking the Model 8500
Confirm that the items listed below are packed with the 8500 Handheld
Pulse Oximeter. The 8500 shipment includes:
• 8500 or 8500M Handheld Pulse Oximeter
• Operator’s Manual for Models 8500 and 8500M Pulse Oximeter
• Six AA batteries
• One sensor
If any item on this list is missing or damaged, contact your distributor.
Contact the carrier immediately if the shipping carton is damaged.

4
Introduction
Indications for Use
The NONIN®8500 Handheld Pulse Oximeter is indicated for measuring
and displaying functional oxygen saturation of arterial hemoglobin (SpO2)
and pulse rate for adult, pediatric, and neonatal patients in hospital,
ambulatory, home, and EMS (emergency medical service) environments.
The 8500 is intended for spot-checking and/or continuous monitoring
when attended by a trained healthcare professional.
General Description
The Model 8500 is a digital handheld pulse oximeter that displays numeric
values for blood oxygen saturation and pulse rate. It typically operates for
100 hours continuously between alkaline battery replacements and
requires no routine calibration or maintenance other than battery
replacement.
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.
Oxygen saturation and pulse rate values are displayed by light-emitting
diode (LED) digital displays. On each detected pulse, the pulse quality
LED blinks. Patient pulse quality signals are graded as good, marginal, or
inadequate and are indicated as such by the pulse quality indicator blinking
green, yellow, or red, respectively. This simple method gives the user a
pulse-by-pulse visual indication of waveform signal quality without
requiring complex waveform analyses.
The Model 8500 pulse oximeter may be used with a variety of NONIN
pulse oximeter sensors.
Because the Model 8500 has no patient alarms, SpO2and pulse rate
displays must be observed frequently.
A sensor disconnect or malfunction is indicated by a lack of good pulse
quality blinking and/or a dash to the left of the SpO2 value on the LED
display. When adequate pulse signals are not received, the SpO2and/or
pulse rate numeric values will be replaced by dashes. Low and critically
low battery conditions will be indicated by the low battery LED.

5
Basic Operation
Installing Batteries
CAUTION! Do not use different types of batteries at the same time, and
do not mix fully- and partially-charged batteries at the same
time time. Battery leakage might result.
Do not remove any covers (except the battery cover) when
replacing batteries.
Follow local ordinances and instructions regarding disposal
or recycling of the device and components, including
batteries. Batteries may leak or explode if used or disposed of
improperly.
Remove the batteries to avoid the risk of leakage if the Model
8500 will be stored for more than one month.
The 8500 Pulse Oximeter is powered by 6 AA Alkaline cells that will
typically provide 100 hours of continuous operation. The 8500 indicates
when the batteries are low by flashing the digital displays once each second. When the
displays begin flashing, the batteries should be replaced as soon as
possible. Replace the batteries by removing the battery door on the
bottom of the 8500. Be sure to follow the polarity markings on the rear
label of the pulse oximeter when installing new batteries. Refer to Figure
I for an illustration of battery replacement.
Rechargeable Nickel Cadmium batteries may be used in the 8500 if
desired. Since NiCad batteries have less than half the capacity of alkaline
batteries, the batteries will have to be recharged more often than every
100 hours.
NOTE: Reducing the display brightness can extend battery life
up to 100%.
NOTE: Replacing batteries erases the memory and clock
settings of the 8500.
NOTE: Batteries should be removed if the 8500 is going to be
stored for more than 30 days. Batteries may leak if left in
the device for a long period of time.

6
Figure I: Replacing Batteries in the 8500

7
Connecting Sensors
Connect the sensor to its 9-pin mating jack on the top of the 8500 as
shown in Figure II. If additional cable length is necessary, connect the
Model 8500I Patient Cable between the sensor and the 8500 Pulse
Oximeter. Position the appropriate sensor on the patient.
Figure II: Connecting Sensors to the 8500
Turning on the Pulse Oximeter
Turn on the Model 8500 by pressing the "" button on the front of the
pulse oximeter. Refer to Figure III.
When the 8500 is powered on, the SpO2and ♥displays will cycle through
the following sequence before displaying valid data values:
• ""
• time saved in memory in hours and minutes
• software revision number
• " - - "

8
Figure III: Front View of the 8500
Figure IV: Rear View of the 8500

9
Verifying Operation
CAUTION! The 8500 must be able to measure the pulse properly to
obtain accurate SpO2measurement. Verify that nothing is
hindering the pulse measurement before relying on the SpO2
measurement.
Verify that the sensor is properly positioned, and ensure that the system is
sensing adequate perfusion by observing that the (perfusion)
indicator is blinking green, and the blinking is correlated to the pulse rate
for 10 seconds. Should the perfusion light be red or yellow or flashing
erratically, reposition the sensor or try a different sensor.
Cleaning the Pulse Oximeter
CAUTION! Do not immerse the 8500 in liquid, and do not use caustic or
abrasive cleaning agents.
The 8500 Pulse Oximeter may be cleaned with a mild detergent and a soft
cloth or with an isopropyl alcohol wipe. Allow enough time for the 8500
to dry thoroughly before reusing.

10
Features
Controls
All functions of the 8500 are controlled by switches found on the front of
the unit. Refer to Figure III for an illustration of these switches.
Power
Pressing the ON switch ("") causes power to be applied to all internal
circuitry. Pressing the OFF switch ("∅") causes power to be removed
from the displays and puts the pulse oximetry circuitry into a low power
standby mode.
In order to conserve battery life, the 8500 automatically powers off after
10 minutes of inactivity. Inactivity is indicated by dashes on the displays
and is caused by:
• no sensor connected to the pulse oximeter
• patient pulse too low
• sensor not attached to a patient
Each time a reading is displayed, the 10 minute timer is restarted.
The "" switch has additional clock and printer mode setting functions
when used in conjunction with the "×" switch.
Display Brightness
The arrow switch ("×") causes the brightness of the digital displays to
change. When powered up, the digital display defaults to the maximum
brightness. Pressing the "×" will advance the brightness to the lowest
setting, and each subsequent press will advance the brightness through 8
different settings. The function is circular, which means it will cycle
through the entire brightness range and then start at the beginning again.
Lower brightness may be used to preserve battery life; higher brightness
may be used to view the displays from a distance.
NOTE: Reducing the LED display brightness can extend battery
life up to 100%.
The "×" switch has additional clock mode setting functions when used
with the "" switch.

11
Setup Mode
Setup mode is used to control the internal time-of-day clock and the
external real-time printer (purchased separately). The setup mode is
initiated by holding the "×" switch when the unit is turned on by pressing
the "" switch. In setup mode, the "" switch and the "×" switch are
used to make the selections.
Advance to the next sequential mode by pressing the "" switch. Each
time the "×" switch is pressed, the number on the ♥display will
increment. It starts with the current value stored in memory for the
parameter designated in the SpO2display. When the correct value appears
in the ♥display, pressing the "" switch will advance the SpO2display to
the next sequential parameter as listed in Table I. This process is
continued until all parameters are set. The settings can be checked easily,
since the first value displayed for each parameter represents the current
setting. When the setting sequence has been completed, the 8500 exits
setup mode and begins normal operation.
Appears in Range of Values
Sequence SpO2Display From To
Printer 00 15
Year 00 99
Month 00 12
Day 01 31
Hours 00 23
Minutes 00 59
Table I: Printer, Clock, and Calendar Mode Parameters
Printer Settings
NOTE: The 8500P prints real-time data only. Data stored in the
8500M can not be downloaded to the 8500P.
"" will appear in the SpO2display, indicating print setup mode. There
are 16 options for the printer mode: 00 through 15.
The modes determine how often and in which format data is written to
the printer. Refer to Figure V for a flowchart of setting the printer mode.
When the printer setting sequence is completed, the 8500 continues to the
calendar settings.

12
Display
Press Press
Proceed to
calendar setup
Default
Setting
Press Press
Display
SpO2
Setup
Mode
Increment
printer
mode
Figure V: Flow Chart for Setting Printer Mode
Printer
Mode
Seconds
per data
point
Minimum
SpO2
printed?*
Touch
print
capability?**
00 10 No Yes
01 30 No Yes
02 120 No Yes
03 10 Yes Yes
04 30 Yes Yes
05 120 Yes Yes
15 --- No Yes
*For modes where the minimum SpO2 data is written, there are two lines of data
written for each data output. The first line contains the minimum value for SpO2
since the last printout, and the second line contains the current data values.
** The touch print mode enables the user to print out data at any time. This is
activated by pressing the "" switch.
Table II: 8500P Printer Modes

13
Calendar Settings
After the printer setting has been determined in the setup mode, " " will
appear in the SpO2display, indicating calendar setup mode for the year.
The year may be set to "00" through "99". After selecting the year, the
display will show " ," indicating the setup mode for the month. The
month may be set to "00" through "12". After selecting the month, the
display will show " ," indicating the setup mode for the day of the
month. The day may be set to "01" through "31". Refer to Figure VI for
a flowchart of setting the calendar. When the calendar setting sequence is
completed, the 8500 continues to the clock settings.
NOTE: Setting the month to "00" disables the clock function and
helps conserve battery life.
Display
Press
Default
Setting
Press
Display
SpO2
Setup
Mode
Press
Press
Press
Press
Press
Press
Increment
year
Press
Increment
month
Press
Increment
day
Proceed to
clock setup
Press
Press
Figure VI: Flow Chart for Setting Calendar

14
Clock Settings
After the calendar settings have been determined in the setup mode, " "
will appear in the SpO2display, indicating clock setup mode for the hour.
The hour may be set to "00" through "23". After selecting the hour, the
display will show " ," indicating the setup mode for the minutes. The
minutes may be set to "00" through "59". After selecting the minutes, the
display will return to normal operation. Refer to Figure VII for a
flowchart of setting the clock.
Display
Press
Default
Setting
Press
Display
SpO2
Setup
Mode
Press
Press
Press
Press
Press
Increment
Press
Increment
hour
Proceed to
minute
normal operation
Figure VII: Flow Chart for Setting Clock
Printer modes determine how often and in which format data is written to
the printer. For modes where the minimum SpO2data is written, two
lines of data are written for each data output. The first line contains the
minimum value for SpO2since the last printout, and the second line
contains the current data values. Touch print mode enables users to print
data at any time by pressing the "" switch.

15
Displays
SpO2Display
The left digital display is a 3-digit light emitting diode (LED) digital
display that indicates oxygen saturation percentage. Refer to Figure III.
♥(Pulse Rate) Display
The right digital display is a 3-digit LED digital display that indicates pulse
rate in pulses per minute. Refer to Figure III.
(Perfusion) Indicator
The perfusion indicator (identified by the waveform symbol ) will
flash once for each pulse while measuring oxygen saturation. The
perfusion indicator changes color to indicate changes in the pulse
waveform signal that may affect SpO2data.
The perfusion indicator may blink one of three colors: green, yellow, or
red. These colors are similar to the colors of a stoplight such that:
Red indicates the pulse amplitude is too small. During red perfusion,
SpO2and pulse rate values are not updated. After ten seconds, values are
replaced with dashes, indicating SpO2measurement is not possible.
Yellow indicates the pulse waveform amplitude is marginal or the pulse
oximeter has detected artifact. Although SpO2data is acceptable,
corrective measures should be considered to improve sensor placement,
change sensor type, or reduce patient movement.
Green indicates a good pulse waveform signal and accurate SpO2data.
CAUTION! The 8500 might interpret motion as good perfusion.

16
Flashing Display
The numerical displays will flash once each second if the 8500 determines
that a battery low condition exists. Replace all six batteries immediately.
NOTE: Inaccurate SpO2and/or pulse rate measurement might
result if the 8500 is operated in a low battery condition.
Dash in SpO2Display
If the 8500 determines that a sensor fault exists (sensor disconnect, sensor
failure, or sensor dislodgment), a dash (-) appears in the left-most digit of
the SpO2display. The readings displayed will remain unchanged while the
sensor fault exists. If the sensor fault is not corrected, dashes will be
displayed 10 seconds after the minus sign appears.