Nonin 8500, 8000M User manual

Operator’s Manual

®

8500 & 8500M

®

8500 & 8500M

Handheld

Pulse Oximeters

0123

1

English

.

CAUTION: Federal law (USA) restricts this device to sale
by or on the order of a licensed practitioner.

Consult Instructions for Use.

NONIN® reserves the rig ht to m ake c hange s and impro veme nts to thi s
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

[phone] (USA and Canada)

[phone]

Fax [phone]

E-mail: [e-mail]

www.nonin.com

0123

EC

REP

Authorized EC Represent ative :

MPS, Medical Product Service GmbH

Borngasse 20

D-35619 Braunfels, Germany

References to “NONIN” in this manual shall imply Nonin Medical, Inc.

NONIN, Flexi-Form, FlexiWrap, PureLight and nVISION are registered
trademarks or trademarks of NONIN Medical, Inc.

Microsoft® and Windows® are registered trademarks of Microsoft Corporation.

© 2007 NONIN Medical, Inc.

6130-001-01

Contents

Guide to Symbols ...............................................................1

Indications for Use .............................................................2

Contraindications ......................................................................2

Warnings ...................................................................................2

Cautions .................................................................................... 3

Displays and Indicators .....................................................7

SpO2 Display ............................................................................7

Pulse Rate Display ....................................................................7

Pulse Quality Display .................................. ..............................7

Low Battery Indicator ......................................................... .......7

Sensor Fault or Inadequate Signal Display ...............................7

Using Model 8500 Series Pulse Oximeter ........................9

Unpacking Model 8500 Series ..................................................9

Installing and Using the Batteries ..............................................9

Important Notes about Battery Use .........................................11

Connecting the Sensor ............................................................12

Turn On/Off .............................................................................12

Startup Self-Test .................................... ..... ............................13

Detailed Operation ...........................................................14

Setup Mode .............................................................................14

Care and Maintenance .....................................................16

Visual Indicators ................................. ...... ....... ...... ....... ...17

Memory Functions (8500M only) ....................................18

Memory Download (8500 only) ...............................................19

Communications .......................... .................................... 20

Serial Output .......................................... .................................20

Service, Support and Warranty .......................................21

Warranty .................................................................................. 22

Accessories ............... ....................................................... 23

Troubleshooting ........................................ ....................... 25

Technical Information ......................................................28

Manufacturer’s Declaratio n .....................................................29

Equipment Response Time .....................................................33

Testing Summary ....................................................................34

Specifications ..........................................................................35

i

Guide to Symbols

S

S

|

This table des cri bes the symbols that are found on the Models 8500 and
8500M.

Consult Instructions for Use.

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

UL Mark for Canada and the United States with respect to electric

I

S

F

I

E

A

D

L

C

C

shock, fire, and mechanical hazards only in accordance with UL

U

L

U

60601-1 and CAN/CSA C22.2 No. 601.1.
CE Marking indicating conformance to EC directive No. 93/42/EEC

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concerning medical devic es .

SN

IPX2

SpO

♥

Ø

×

Serial Number (located on the back cover).
Protected against vertically falling water drops when enclosure is

tilted up to 15 degrees per IEC 60529.
Indicates separate collection for electrical and electronic equipment

(WEEE).
%SpO2 Display

2

Pulse Rate Di splay

Pulse Quality Indicator

No Alarms

Front Panel Buttons

ON

OFF

Advance/Dimmer Button

1

Indications for Use

NONIN® Models 8500 and 8500M Handheld Pulse Oximeters are
indicated for use in measuring and displaying functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediat ric,
and neonatal patients in hospitals, ambulatory, home and EMS
environments. Models 8500 and 8500M are intended for continuous
monitoring and/or spot-checking of patients when attended by a
healthcare professional.

Contraindications

Do not use this device in an MR environment.

Explosion Hazard: Do not use in an explosive atmo sph ere or in the
presence of flammable anesthetics or gasses.

This device is not defibrillation proof per IEC 60601-1:1990
clause 17h.

Warnings

This device is intended only as an adjunct in patient assessment. It
must be used in co nj unc tio n w i th o ther methods of assessing clinical
signs and symptoms.

Oximeter readings of this device may be affected by the use of an
electrosurgical unit (ESU).

Use only with NONIN-branded PureLight® pulse oximeter sensors.
These sensors are manu factured to meet the accuracy spec ifications
for NONIN Pulse Oximeters. Using other manufacturers’ sensors
may cause improper pulse oximeter performance. Using other
manufacturers’ sensors can result in improper pulse oximeter
performance.

Do not use a damaged sensor. If the sensor is damaged in any way,
discontinue use immediately and replace the sensor.

2

Warnings (Continued)

As with all medical equipment, carefully route patient cabling to
reduce the possibility of patient entanglement or strangulation.

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 may result in increased emission and/or decreased
immunity of this device.

This device is a prec isio n elec tronic instru ment and mu st be rep aire d
by qualified technical professionals. 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.

This device must be able to measure the pulse properly to obtain an
accurate SpO

pulse measurement before relying on the SpO2 measurement.

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

Discontinue use of adhesive tape strips if the patient exhibits an
allergic reaction to the adhesive material.

measurement. Verify that nothing is hindering the

2

Do not stretch the adhesive tape while applying the pulse oximeter
sensor. This may cause inaccurate readings or skin bliste rs.

The device turns of f after approxi matel y 10 min utes w hen at cri tical ly
low battery capacity.

.Cautions

Before use, carefully read the Instructions for Use provided with the

sensors.

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.

3

.Cautions (Continued)

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 assist a nc e.

The presence of a defibrillator may interfere with the performance of
this device.

This device ma y not w ork o n all p ati ent s. If you a re unab le to a chiev e
stable readings, discontinue use.

This device has moti on tolerant s oftware th at minimize s the likeliho od
of motion artif act b ein g m is in t erp rete d as good pulse qual ity. In some
circumstance s, however , th e device may s till interpret mo tion as good
pulse quality. Minimize patient motion as much as possible.

Ear Clip and Reflectan ce sen sors are not recomm ended for pediat ric
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 ci rcu lati on , or
reposition the sensor.

The device is not designed to retain data in memory once the
batteries are removed. Memory will clear 3 minutes after removing
the batteries. Replaci ng the ba tteries before 3 minute s have elap sed
most likely will resu lt in corrupt dat a. Always repla ce the batteries with
fully charged batteri es. Do not u se fully c harged and par tially ch arged
batteries at the same time as this may cause the batteries to leak.

Use only NONIN-specified battery types with this device.

4

.Cautions (Continued)

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 60601-1-2:2001/A1:2004 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 , beca us e of the proliferation of radio-frequenc y tran sm itting
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 dist ributor’s contact information.

Portable and mobile RF communications equipment can affect
medical electrical equipment.

5

.Cautions (Continued)

This device is designed to determine the percentage of arterial
oxygen saturation of functional hemoglobin. Factors that may
degrade pulse oximeter performance or affect the accuracy of the
measurement include the following:

- excessive ambient lig ht

- 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.

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 data­processing equipment.

This device is a precision electronic instrument and must be repaired
by trained NONIN personnel only.

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.

6

Displays and Indicators

SpO2 Display

The SpO2 display 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 Ind icator dis play (ide ntified 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 dif ferent sensor typ e, reduce pati ent
movement, or improve the site’s circulation.

• Red indicates an inadequate pulse strength signal. While the Pulse
Quality display is red, SpO
After about 10 seconds, the values are replaced with dashes,
indicating that readings are not possible.

and pulse rate values are not updated.

2

♥

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 determin es that a s ensor fault or inad equate signa l condition
exists (a sensor disconnect, failure, misalignment or incompatibility with
the monitor) or if a pulse oximeter sensor sign al is no lon ger dete ct ed, a
dash (-) appears in the leftmost pos ition of the SpO
that are displaye d w il l f reez e for 10 seconds if the pul se ox im ete r s ens or
fault or the inadequate signal continues.

display . The readings

2

7

If the sensor fault or the inadequate signal is not corrected, the frozen

%
S

te

ty

n

n

readings and the da sh in t he lef tmos t posi tio n will b e repla ced by dashe s
in the middle of both the SpO2 and the Pulse Rate displays.

When the sensor faul t or the ina dequate signal i s corrected, the SpO

and

2

pulse rate displays will return to normal operation.

Oxygen

aturation

Advance/Dimmer
Button

Heart Ra

Pulse Quali
Indicator

On Butto

Off Butto

8

Using the 8500 and 8500M Pulse Oximeters

Unpacking the Model 8500 and 8500M

The Models 8500 and 8500M systems includes the following items:

• 1 Model 8500 or 8500M Pulse Oximeter

• 1 Model 8500 or 8500M Operator’s Manual on CD

• 1 NONIN 8000AA Pulse Oximeter Sensor

• 6 AA-Size Alkaline Batteries

Confirm tha t the items listed are included with the system. If any item on
this list is missing or damaged, conta ct your distributor . Cont act the carrier
immediately if the shipping ca rton is damag ed .

Installing and Using the Batteries

Models 8500 and 8500M are powered by 6 AA-size alkaline batteries.

CAUTION: Use only NONIN-specified battery types with this

!

device.

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 batt ery com pa rtment. Pro per batter y posit ion ing
is essential for correct operation.

3. Replace the battery co ver and turn the device on. If the device does

not turn on, see “Troubleshooting.”

CAUTION: The device is not designed to retain data in memory

!

once the batteries are rem oved. Memory will clear 3 mi nutes af ter
removing the batteries. Replacing the batteries before 3 minutes
have elapsed most likely will result in corrupt data. 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