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

0123

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

Figure 1: Installing Batteries in the 8500

When batteries are critical ly low, the digital displays wil l go blan k, and th e
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 af ter approxi mately 10 minu tes when

at critically low battery capac ity.

CAUTION: Replace the batteries as soon as possible after a low

!

battery indication. Always replace the batteries with fully charged
batteries. Do not use full y charg ed and p artial ly cha rged batt erie s
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

Important Notes about Battery Use

Six AA alkaline batteries provi de the device with approx imately 100 hours
of continuous operation.

Display brightness c an af fect bat tery life ; the lo wer settin gs wil l cons erve
battery life.

Clock/calendar settings can affect battery sto rage life. Batterie s 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, alkal ine batteries
will need replacement in 10-12 months if the unit has not been used.

• If the clock/calen dar is set when the unit is stored an d if the unit has n ot
been used, alkaline batteries will require replacement in about 6
weeks.

11

Connecting the Sensor

Connect the pulse ox imeter sensor (wit h the NONIN logo fa cing 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 2: Connecting a Sensor

Turn On/Off

• Tur n on the device by pressing the ON ( | ) button.

• Tur n off the device by pressing the OFF (Ø) button.

To conserve battery life, the device automatically powers off after 10
minutes of inactivi ty. Inactivity is indicated by dashe s on t he dis plays and
may result from an improperly connected or positioned sensor , or from an
inadequate patient pulse signal.

The Advance/Dimmer button controls the brightness of the digital
displays. When turned on, the digital display defaults to the maximum
brightness. Pressing the Advance/Dimmer button will decrease the
brightness to the lowest s etting, and each subsequent pres s will increase
the brightness th roug h 8 different setting s. Low e r bri ghtness settings will
conserve battery life.

NOTE: Reducing th e LED displ ay br igh tness c an ex tend battery life up t o

60%.

12

Startup Self-Test

When the device is turned on, the device will cycle through a startup/
initialization se quence before displaying valid data. During st artup, always
check for any mis sing indicator s or LED displ ay segments. If any indica tor
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 SpO2 and Pulse Rate displays.

• 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): Main
revision “r” + 3 numbers (8500 & 8500M ); M emory revisi on “n ” “n” (fo r
m) + 3 numbers for Model 850 0M; the 8500 w ill display “n” “n” an d “no”
for Model 8500.

• ( - ) a dash appears for Model 8500 in the displays until a valid pulse
signal is detected.

Apply the pulse ox imeter senso r to th e patien t’s fin ger; 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 SpO2 readings are displayed

• the Pulse Quality indicator is blinking in time with the pulse rate for at
least 10

If the Pulse Quality indicator is blinking red or amber or is blinking
inconsistently, reposition the sensor or replace the sensor.

The SpO2 and Pulse Rate w ill di splay a si ngle d ash un til a pul se si gnal i s
detected.

seconds

13

Detailed Operation

Setup Mode

Setup mode is used to:

1. Set the calendar and clock.

2. Memory download function (8500M only).

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 the Advance/Dimmer button

while pressing and then rele asing the ON (
year will appear.

2. Release the Advance/Dim m er but ton whe n 888 888 appears in

the SpO
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 S pO
complete. The device is ready for use.

and Pulse Rate displays. The current time and year

2

and Pulse Rate disp lays when S et-Up is

2

| ) button; the month and

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 Y 07 (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 SpO2 and Pulse Rate displays when Set-up is
complete. The device is ready for use.

14

1

See the table below for display sequence, appearance, and range.

Year
Month
Day
Hours
Minutes

Sequence

SpO2 Display

y 00 - 99

nn 00 - 12

d 01 - 31
h 00 - 23

nn 00 - 59

Range

15

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.

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 abrasi ve cleaning agents on the

!

device or the sensors.

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 ope nin gs in the device. Allow th e d ev ic e
to dry thoroughly before reusing.

16

Visual Indicators

The following table descr ibes condi tions and visual indicators.

Condition Visual Indication

Pulse Wave form Signal

is inadequate

Sensor fault (i.e. sensor

disconnect, failure, or

incompatibility with the

monitor)

Inadequate Signal

(Sensor misalignment,

ambient light, nail

polish/artificial nai ls ,

etc.)

Inadequate SpO

2

pulse rate data

(excessive motion or

erratic heart rate, etc.)
more than 20 seconds

Pulse rate data not

updated for more than

30 seconds

Low Battery

• Pulse Quality LED blinks red

• Pulse Quality LED blank

• Dash (-) appears in the leftmost position
of the SpO

•SpO

display

2

and Pulse Rate numeric displays

2

freeze for 10 seconds

• After 10 seconds a dash (-) replaces the

and Pulse Rate numeric displays.

SpO

2

• Pulse Quality LED blinks

• Dash (-) appears in the leftmost position
of the SpO

•SpO

display

2

and Pulse Rate numeric displays

2

freeze for 10 seconds

• After 10 seconds a dash (-) replaces the

and Pulse Rate numeric displays.

SpO

2

or

• Dash (-) appears in SpO

2

displays

• Pulse rate numeric display becomes

dashes

•SpO

and Pulse Rate displays blink.

2

and pulse rate

Critically Low Battery

•SpO

and pulse rate displays are

2

blinking dashes

• Pulse Quality LED is solid red or amber

17

Memory Functions (8500M only)

Each time Model 8500M is turned on (except during Setup mode), data
are automatically collected in memory. The device can collect and store
up to 72 hours of SpO2 and pulse rate information.

NOTE: The device is not designed to retain data in memory once the

batteries are removed. Only rec ording sess ions l onger t han 1 m inute are
stored in memory. Memory will clear 3 minutes after removing the
batteries. Replacing the batteries before 3 minutes have elapsed most
likely will result in corrupt data.

NONIN’s nVISION data management software is available for use with
Microsoft Windows 95/98/2000/NT 4.0/XP operating systems. Refer to
“Accessories.”

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 devic e is turned on, the cu rrent time/dat e information (if the
clock is set correct ly) is stored in memory to all ow qu ick di fferentiation of
recording sessions. Patient SpO
every 4 seconds.

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 pul se pe r m in ute in the interval from
18 to 200 pulses per mi nute, and i ncrement s of 2 pulses per m inute in the
interval from 201 to 300 pulses per minute.

and pulse rate are sample d an d stored

2

18

Memory Download (8500M only)

NOTE: Downloading the data in memory does not clear the memory.

Downloading the Data Stored in Memory

1. With the device off, press and hold the Advance/Dimmer button
while pressing the ON ( | ) button.

2. Release the Advance/Dim mer button whe n 888 888 is d ispla yed
on the S pO
memory (04 41 for example) appears briefly in the displays and
y 07 appears (for example).

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 until the data is rewritten or the
batteries are removed for at least 3 minutes.

and pulse rate LEDs. The clock time currentl y set in the

2

19

Communications

Serial Output

Models 8500 and 8500M provide 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.

Pulse Oximeter Sensor Connector Pin Assignments

Pin

Number Assignment

1
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.

1-Wire

®

NOTE: The 9th data bit is used for odd parity in me mor y downl oad . 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. At start up a header is sent identifying th e for mat and the
date and time as HH:MM:SS, where “HH” represents the hour, “MM”
represents the minutes, and “SS” represents the seconds. The data are
sent once per second in the following format:

SPO2=XXX HR=YYY

where “XXX” represents the S pO2 value, and “YYY” represents the pul se
rate. The SpO
available.

20

and pulse rate will be displayed as “---” if no data is

2

Service, Support a nd Warranty

CAUTION: This device is a precision electronic instrument and

!

must be repaired by trained NONIN personnel only.

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 digit al circuitry within Models 8500 and 8500M require no
periodic maintenance or calibration. NONIN does not recommend field
repair of Models 85 00 and 850 0M . Th e c irc uit boa rd in Models 8500 and
8500M is a multi-layer board using very narrow traces. Due to the very
small trace size , extreme care m ust be used w hen repla cing co mponent s
to prevent permanent, non-repairable damage to the circuit board. Most
components are s urface-mounted and requ ire special hot-air jet so ldering
and desoldering eq uipment. After any repairs are made , Models 8500 and
8500M 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

[phone] (USA and Canada)

All non-warranty work shall be done according to NONIN standard rates
and charges in ef fect at th e time of deliv ery to N ONIN. All rep airs in clude
a complete retest of Models 8500 and 8500M using factory test fixtures.

[phone]

Fax [phone]

E-mail: [e-mail]

www.nonin.com

21

Warranty

NONIN MEDICAL, INCORPORATED, (NONIN) warrants to the
purchaser, for a period of three years from the date of purchase, each
Model 8500 or 8500M 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 8500 or 8500M found to be defective in
accordance with th is warrant y, free of charge, for which NONIN h as been
notified by the purchaser by seri al number that there is a def ect, 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 8500 or 8500M 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.
For any Model 8500 or 8500M sent to NONIN for warranty repai r which i s
found to be within specifica tion, the purchaser agrees to pay $100.00 (US
dollars).

The Model 8500 or 8500M 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 8500 or
8500M, field servic e b y n on -N ONIN pers on nel , t a mpering, or any kind of
misuse or abuse of the Model 8500 or 8500M, 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.

22

Accessories

The following NON IN accesso ries functio n with Models 8500 and 8500M.
Detailed information regarding specific sensor use (patient population,
body/tissue, and application) can be found in the respective sensor
Instructions for Use.

Model

Number

HHCC 8500CC-B Handheld Carrying Case (Black)

8500/INS Operator’s Manual for Models 8500/8500M

8500RB Rubber Bumper

8500MB-PMS Mounting Bracket with Pole Mount System

8500MB Mounting Bracket

8500TS Table Top Stand

PC Pole Mount Clamp

Pulse Oximeter Reusable Sensors

8000AA-1 Adult Articulated Finger Clip Sensor (1 meter)
8000AA-3 Adult Articulated Finger Clip Sensor (3 meter)
8000AP-1 Pediatric Finger Clip Sensor (1 meter)
8000AP-3 Pediatric Finger Clip Sensor (3 meters)

8000J-1 Adult Flex Sensor (1 meter)
8000J-3 Adult Flex Sensor (3 meters)

8008J Infant Flex Sensor (1 meter)
8001J Neonatal Flex Sensor (1 meter)

8000R Reflectance Sensor (1 meter)

Description

23

Model

Number

Description

Other Accessories

nVISION

nVISION
2000/NT 4.0/XP operating systems (8500M only)

®

Software for Microsoft Windows 95/98/

8000JFW Adult FlexiWrap Sensor Wrap
8008JFW Infant FlexiWrap Sensor Wrap
8001JFW Neonatal FlexiWrap Sensor Wrap

8000H Reflectance Sensor Holder System

UNI-RA-0 7.5” 90-degree patient cable

UNI EXT Patient Extension Cable

Memory Cable (for use between Model 8500M and a

1000MC

PC running Microsof t Windows 95/9 8/2000/NT 4.0 /XP
operating systems)

Serial cable, Memory or Real-Time (May be used for

1000RTC

real-time interface to a PC; this application IS NOT
supported by nVision software.)

For more information about NONIN parts and accessories contact your
distributor, or contact NONIN at [phone] (USA and Canada) or
[phone].

WARNING: The use of accessories, sensors, and cables other than

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

WARNING: Use only with NONIN-brande d PureLight

®

pulse oximeter
sensors. These sensors are manufactured to meet the accuracy
specifications for NONIN Pulse Oxim eters. Using other manufacturers’
sensors may cause improper pulse oximeter performance. Using other
manufacturers’ sensors can result in improper pulse oximeter
performance.

24

Troubleshooting

Problem Possible Cause Possible Solution

The device won’t
turn on.

A dash appears in
the leftmost
position of the

display.

SpO

2

Dashes are
displayed in both
the SpO

Rate displays.

and Pulse

2

The batteries are
depleted.

The batteries are
installed in correctly.

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.

Sensor failure. Replace the sensor.

Replace all 6 batteries.

Verify battery
orientation, illustrated
inside the battery
compartment or in
Figure 1: Installing
Batteries in the 8500
section of this
operator’s manual.

Contact NONIN
Technical Service.

Verify that the sensor
is correctly connected
to the device and the
patient; replace sens or
if the condition
persists.

Verify the sensor
connections.

Numeric displays
are blinking at
once per second.

Low batteries. Replace all 6 batteries.

Incorrect battery
installation.

Verify battery
orientation.

25

Problem Possible Cause Possible Solution

The displayed
pulse rate does not
correlat e to the
pulse rate
displayed on the
ECG monitor.

An inconsistent
Pulse Rate or an
amber Pulse
Quality display
during the use
with
electrosurgical unit
(ESU).

Excessive motion at the
sensor site may be
prohibiting the device
from detecting a
consistent pulse signal.

The patient may have an
arrhythmia resulting in
some heart beats that do
not detect a p ulse qu ality
signal at the sensor site.

A non-compatible sen sor
is being used.

The ECG monitor may
not be functioning
properly.

The ESU may be
interfering with the pulse
oximeter performance.

Eliminate or reduce
the cause of the
motion or
the sensor to a new
sensor site.

Assess the patient.

Replace the sensor
with a NONIN-branded
Purelight sensor.

Assess the patient.

Assess the patient.
Move the device,
cables, and sens ors as
far away from the ESU
as possible.

reposition

The Pulse Quality
LED is blinking
amber with each
pulse.

Numeric display
segments are
missing.

Degradation of
device
performance.

26

The quality of the pulse
signal at the sensor site
is inadequate.

Defective LEDs.

Electromagnetic
interference (EMI).

Assess the patient.
Reposition sensor or
select an alternate
sensor site.

Discontinue use of the
device.

Remove the device
from the EMI
environment.

Problem Possible Cause Possible Solution

Pulse Quality LED
does not blink
green.

The Pulse Quality
display is blinking
red and the SpO

2

and/or Pulse Rate
displays are
dashes.

Inadequate pulse signa l

or

the sensor is not

Reposition the sensor.

correctly positioned.

Remove the restriction
The sensor is restricting
blood circulation at the
sensor site.

to increase blood

circulation at the

sensor site or

the sensor.
Excessive ambient light. Reduce ambient light.
Excessive patient

motion.
The patient is wearing

nail polish or artificial
nails.

Reduce patient

motion.

Remove nail polish or

artificial nails.

Performance
degradation from:

• arterial catheter

• blood pressure cuff

Reduce or eliminate

the source.

• infusion line

Assess the patient.
Inadequate signal at
sensor site.

Reposition sensor or

select an alternate

sensor site.

relocate

Inadequate pulse signa l
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 [phone] (USA and
Canada) or [phone].

27

Technical Inform ation

NOTE: This product compli es w ith ISO 109 93 -1, Biol ogi ca l 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 leas t IEC Standard
EN 60950 or UL 1950 for data-processing equipment.

CAUTION: Portable and mobile RF communications equipment

!

can affect medical electrical equipment.

28

Manufacturer’s Declaration

Refer to the following t able for specifi c information re garding this devic e’s
compliance to IEC 60601-1-2.

Table 1: Electromagnetic Emissions

Electromagnetic

Emissions Test Comp liance

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

Class B

N/A

N/A

Environment—Guidance

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.

This device is suitable for use in all
establishments, including domestic
and those directly connected to the
public low-voltage power supply
network that supplies buildings used
for domestic purposes.

29

Table 2: 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.

Electrostatic
Discharge (ESD)

IEC 61000-4-2

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

Power
Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8

is the AC mains voltage before application of the test level.

Note: U

T

±6 kV contact
±8 kV air

±2 kV for power
supply lines
±1 kV for input/
output lines

±1 kV differential
mode
±2 kV common
mode

±5% U

T

(>95% dip in UT)
for 0.5 cycle
±40% U

T

(60% dip in UT)
for 5 cycles
±70% U

T

(30% dip in UT)
for 25 cycles
<5% U

T

(>95% dip in UT)
for 5 sec.

3 A/m 3 A/m

±6 kV contact
±8 kV air

N/A

N/A

N/A

N/A

N/A

Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.

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
magnetic fields should be
at levels characteristic of
a typical location in a
typical commercial or
hospital environment.

30

Table 3: Guidance and Manufacturer’s Declaration—

Electromagnetic Immunity

Immunity

Test

IEC 60601
Test L evel

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.

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms

150 kHz to

80 MHz

3 V/m

80 MHz to

2.5 GHz

3 V

3 V/m

Recommended Separation Distance

d 1.17 P=

d 1.17 P=

d 2.33 P=

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

a

electromagnetic site survey

, should be

less than the compliance level in each
frequency range.

b

Interference may occur in the vicinity of
equipment marked with the following
symbol:

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 stre ngth 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.

31

Table 4: Recommended Separation Distances

This table details the recommended separation dist ances between portable and
mobile RF communications equipment and this device.

This device is intended for use in an electromagnetic environment in
which radiated RF di sturba nces are c ontrolled. Users of this devi ce 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 comm uni ca tio ns 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
1 1.2 1.2 2.3

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 t he 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

d 1.17 P=

80 MHz to

800 MHz

d 1.17 P=

800 MHz to 2.5 GHz

d 2.33 P=

32

Equipment Response Time

SpO2 Values

Standard/Fast Averaged SpO

2

Average Latency

4 beat exponential 2 beats

Pulse Rate Values Response Latency

Standard/Fast Averaged Pulse Rate 4 beat exponential 2 beats

Example - SpO2 Exponential Averag ing

SpO2 decreases 0.75% per second (7.5% over 10 seconds)
Pulse Rate = 75 BPM

100

95
90
85
80

SpO2

75
70
65
60

0.0

SaO2 R eference 4 Beat Average

8.0

16.0

24.0

32.0

40.0

48.0

56.0

64.0

72.0

80.0

Time in seconds

Specific to this example:

• The response of the 4-beat average is 1.5 seconds.

33

Testing Summary

SpO2 accuracy, and low perfusion testing was conducted by NONIN
Medical, Inc., as described below:

SpO2 Accuracy Testing

SpO2 accuracy testing is conducted during induced hypoxia studies on
healthy, non-smoking, light- to dark-skinned subjects during motion and
no-motion conditions in an independent research laboratory. The
measured arterial hemoglobin saturation value (SpO
compared to arterial hemoglobin oxygen (SaO
blood samples with a laboratory co-oxime ter. The accuracy of the sens ors
in comparison to the co-oximeter sample s measured over the S pO2 range
of 70 - 100%. Accuracy data is calculated using the root-mean-squared
(A

value) for all subjects, per ISO 9919:2005, Medical Electrical

rms

Equipment—Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use.

Pulse Rate Motio n Testing

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 9919:2005 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
read. The oximeter must maintain accuracy in accordance with
ISO 9919:2005 for heart rate and SpO2 at the lowest obtainable pulse
amplitude (0.3% modulation).

levels for the oximeter to

2

) of the sensors is

2

) value, determined from

2

34

Specifications

Oxygen Saturation Display Range 0 to 100% SpO
Pulse Rate Display Range 18 to 321 beats per minute (BPM)

Saturation Declared Accuracy (A

rms

)*

70-100%

Adults / Pediatrics Neonates

Finger Clip: ±2 digits N/A

Flex: ±3 digits ±4 digits

8000R: ±3 digits N/A

Pulse Rate Declared Accuracy (A

)* 18 to 300 BPM

rms

Adults / Pediatrics Neonates

Finger Clip:

±3 digits N/A

Flex: ±3 digits ±3 digits

8000R: ±3 digits N/A

Measurement Wavelengths and Output Power**

Red: 660 nanometers @ 0.8 mW max. avg.

Infrared: 910 nanometers @ 1.2 mW max. avg.

Indicators

Pulse Quality Indicator: LED, tricolor

Numeric Displays: 3-digit 7-segment LEDs, red

Temperature (Operating) -20 to +50°C (-4 to +122°F)

Temperature (Storage/T ran sp ort a tio n): -30 to +50°C (-22 to +122°F)

Humidity (Operating) 10 to 90% noncondensing

Humidity (Sto rag e/Transportation): 10 to 95% noncondensing

Altitude (Operating) Up to 12,000 meters (40,000 feet)

Altitude (Hyperbaric Pressure): Up to 4 atmospheres

Power Requirements Six 1.5V AA-size alkaline batteries.

100 hours maximum display
brightness; 160 hours with normal
display brightness.

Dimensions 8 cm W x 15 cm H x 2.5 cm D

(3 in W x 6 in H x 1 in D)

Weight 280 g (10 oz) (with alkaline batteries)

Sensor Families:

Finger Clip Sensors: 8000AA-1, 8000AA-3, 8000AP-1, 8000AP-3
Flex Sensors: 8000J-1, 8000J-3, 8008J, 8001J
* ± 1 A

** This information is especially useful for clinicians performing photodynamic therapy.

represents approximately 68% of measurements.

rms

2

35

Classifications per IEC 60601-1 / CSA601.1 / UL60601-1 30EM

Type of Protection: Internally powered (on battery power)

Degree of Protection: Type BF-Applied Part

Mode of Operation: Continuous

Enclosure Degree of Ingress
Protection

IPX2

36