NONIN 8500, 8500M User manual

Operator’s Manual

Models 8500 & 8500M

Handheld Pulse Oximeters

English

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: [e-mail]

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.

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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

Underwriters Laboratories

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

UL

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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.

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• 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.

2

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.

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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, SpO
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 SpO
display. When adequate pulse signals are not received, the SpO
pulse rate numeric values will be replaced by dashes. Low and critically
low battery conditions will be indicated by the low battery LED.

and pulse rate

2

value on the LED

2

and/or

2

4

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:

NOTE:

NOTE:

Reducing the display brightness can extend battery life
up to 100%.

Replacing batteries erases the memory and clock
settings of the 8500.

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.

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