Operator’s Manual

Model 7500FO

Pulse Oximeter

English
 Follow Instructions for Use.

Nonin® reserves the right to make changes and improvements to this manual and the products it
describes at any time, without notice or obligation.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA

+1 (763) 553-9968
(800) 356-8874 (USA and Canada)
Fax: +1 (763) 553-7807
E-mail: [email protected]

Nonin Medical B.V.

Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands

+31 (0)13 - 79 99 040 (Europe)

Fax: +31 (0)13 - 79 99 042
E-mail: [email protected]

nonin.com

EC REP

MPS, Medical Product Service GmbH

Borngasse 20
D-35619 Braunfels, Germany

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

Nonin, PureLight and nVISION are registered trademarks or trademarks of Nonin Medical, Inc.
Microsoft® and Windows® are registered trademarks of Microsoft Corporation.
© 2019 Nonin Medical, Inc.
5934-001-06
 Contents
Indications for Use ........................................................................................ 1
Warnings ................................................................................................................ 1
Cautions ................................................................................................................. 2
Guide to Symbols .......................................................................................... 4
Displays, Indicators and Controls................................................................ 6
%SpO2 Display....................................................................................................... 6
Pulse Rate Display ................................................................................................. 6
Numeric LEDs ........................................................................................................ 6
Indicators and Icons ............................................................................................... 7
Model 7500FO Front Panel Buttons ....................................................................... 8
Operating the Model 7500FO ...................................................................... 10
Operating Instructions ................................................................................ 11
Operating in the MR Environment ........................................................................ 11
Operating Modes and Defaults................................................................... 12
Setup Mode, Viewing Limits and Setting Time ..................................................... 12
Factory Defaults ................................................................................................... 12
User-Defined Defaults .......................................................................................... 13
Patient Security Mode .......................................................................................... 13
Viewing and Changing Patient Security Mode.................................................. 14
Operator Functions ..................................................................................... 15
Care and Maintenance................................................................................. 18
Cleaning the Model 7500FO................................................................................. 18
Alarms and Limits........................................................................................ 19
High Priority Alarms.............................................................................................. 19
Medium Priority Alarms ........................................................................................ 19
Watchdog Alarms ................................................................................................. 19
Informational Tones.............................................................................................. 19
Alarm Summary.................................................................................................... 20
Patient Alarms................................................................................................... 20
Equipment Alarms............................................................................................. 20
Reviewing and Setting Volume and Alarm Limits .................................... 21
Reviewing, Setting, or Changing Volumes and Alarm Limits ............................... 21
Silencing Alarms................................................................................................... 21
Recalling Previous Settings.................................................................................. 22
Error Codes .......................................................................................................... 22
Memory and Data Output Features ............................................................ 23
Serial Patient Data Output.................................................................................... 23
Analog Output....................................................................................................... 24

i
 Contents (Continued)
Analog Output Calibration..................................................................................24
Memory Features ..................................................................................................25
Clearing Patient Memory ...................................................................................25
Playing Back Memory Data ...............................................................................25
Connecting the Device into a Medical System ......................................................26
Parts and Accessories.................................................................................27
Service, Support, and Warranty..................................................................28
Warranty................................................................................................................28
Troubleshooting ...........................................................................................29
Technical Information ..................................................................................31
Manufacturer’s Declaration ...................................................................................31
Essential Performance.......................................................................................31
Equipment Response Time...................................................................................33
Testing Summary ..................................................................................................34
SpO2 Accuracy Testing .....................................................................................34
Low Perfusion Testing .......................................................................................34
Principles of Operation..........................................................................................35
Specifications ........................................................................................................35

ii
 Figures
Figure 1. Model 7500FO Front View .......................................................................... 6

iii
 Tables
Table 1. Symbols ....................................................................................................... 4
Table 2. Factory Default Settings............................................................................. 12
Table 3. Basic Functions.......................................................................................... 15
Table 4. Limits Display Sequence............................................................................ 15
Table 5. Advanced Functions .................................................................................. 16
Table 6. Electromagnetic Emissions........................................................................ 31
Table 7. Electromagnetic Immunity.......................................................................... 32

iv
Indications for Use

Indications for Use

The Nonin® Model 7500FO Pulse Oximeter is a portable, tabletop device indicated for use in
simultaneously measuring, displaying, and recording functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate of adult, pediatric and infant patients in an Magnetic
Resonance (MR) environment while operating on battery power alone. Testing was performed in
MR conditional environments at 1.5T and 3T. It is intended for spot checking and/or continuous
monitoring of patients who are well or poorly perfused.

Warnings
Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses.
This device is not defibrillation proof per IEC 60601-1.
The battery charger cannot be used in the MR environment.
This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other
methods of assessing clinical signs and symptoms.
Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient
sensitivity to sensors and/or double-backed adhesive strips may vary due to medical status or skin condition.
Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
To avoid patient injury, use only Nonin-branded PureLight® pulse oximeter sensors. These sensors are manufactured to
meet the accuracy specifications for Nonin pulse oximeters. Using other manufacturers’ sensors can result in improper
pulse oximeter performance.
To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and accessories
before use.
No modifications to this device are allowed as it may affect device performance.
Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the
sensor.
Verify all alarm settings and limits during system startup to ensure that they are set as intended.
Do not use this device in or around water or any other liquid, with or without AC power.
As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement,
strangulation, or injury to the patient.
Use this device only with power adapters supplied by Nonin Medical.
This device turns off after approximately 30 minutes when in low battery mode.
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 battery pack must be installed at all times while the device is operating—even when operating on AC power. Do
NOT use the device without batteries.
The use of accessories, sensors, and cables other than those listed in this manual may result in increased
electromagnetic emission and/or decreased immunity of this device.
To comply with relevant product safety standards, ensure that all alarm volumes are set appropriately and are audible in
all situations. Do not cover or otherwise obstruct any speaker openings.

1
 Indications for Use

Warnings (Continued)
When operating in an MR environment, securely fasten this device to a non-movable pole mount or other large object,
and keep it as far from the magnetic field as possible. For magnetic equipment with a magnetic strength of 1.5T or less,
the device must be a minimum of 2 meters away from the magnet.
The fiber cable for this device is extremely sensitive and must be handled with caution at all times. Do not use a
damaged sensor.
To avoid injury or potential equipment damage, always keep the oximeter, battery charger and metal end of fiber optic
cable beyond the distance of magnetic attraction. To ensure safe operation of the 7500FO in the MR environment, the
monitor must be located outside the 200 Gauss line of the MR room and must be firmly attached to a fixed object.
When audible alarms cannot be heard due to ambient noise, visible alarms must be used.
Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the medical electrical system,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.

Cautions
This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or
systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical
installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of
electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close
proximity or strength of a source might disrupt the performance of this device. Medical electrical equipment needs
special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC
information specified in this manual.
When mounting the monitor to a mobile pole, mounting the monitor higher than 1.5 meters (5 feet) or mounting more
than 2 kilograms (4.5 pounds) of equipment onto the pole may result in tipping, damage to the equipment, or injury.
If the device does not beep during the initialization sequence, the speaker may not be functioning properly. Discontinue
use until the situation is corrected by Nonin Technical Service.
Review all limits to ensure they are appropriate for the patient.
Setting alarm limits to extremes can render the alarm system useless.
Do not simultaneously touch the accessible connector pins and the patient.
This device is a precision electronic instrument and must be repaired by Nonin Technical Service. 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.
If this device fails to respond as described, discontinue use until the situation is corrected; contact Nonin Technical
Service.
The sensor might not work on cold extremities due to reduced circulation. Warm or rub the finger to increase circulation,
or reposition the sensor.
Do not gas sterilize or autoclave this device.
Batteries might leak or explode if used or disposed of improperly.
This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good
pulse quality. In some circumstances, however, the device may still interpret motion as good pulse quality.
Do not place liquids on top of this device.
Do not immerse this device or sensors in any liquids.
Do not use caustic or abrasive cleaning agents on the unit or sensors.

2
Indications for Use

Cautions (Continued)
Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the
device and device components, including batteries. Use only Nonin-approved battery packs.
In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not
dispose of this product as unsorted municipal waste. This device contains WEEE materials; please contact your
distributor regarding take-back or recycling of the device. If you are unsure how to reach your distributor, please call
Nonin for your distributor’s contact information.
To prevent potential loss of monitoring or inaccurate data, remove any objects that might hinder pulse detection and
measurement (e.g., blood pressure cuffs).
If the entire memory is filled, portions of the oldest record will be overwritten when a new record begins.
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 light - anemia or low hemoglobin concentrations
- excessive motion - cardiogreen and other intravascular dyes
- electrosurgical interference - carboxyhemoglobin
- blood flow restrictors (arterial catheters, blood - methemoglobin
pressure cuffs, infusion lines, etc.) - dysfunctional hemoglobin
- moisture in the sensor - artificial nails or fingernail polish
- improperly applied sensor - a sensor not at heart level
- incorrect sensor type - residue (e.g., dried blood, dirt, grease, oil) in the light
- poor pulse quality path
- venous pulsations

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.
All parts and accessories connected to the serial port of this device must be certified according to at least IEC Standard
EN 60950, IEC 62368-1, or UL 1950 for data-processing equipment.
Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
The two-minute alarm silence is automatically engaged at startup.
Do not use the power supply if the integrity of the AC cord conductors or the outlet is in doubt.
Failure of a network data coupling (serial cable/connectors) will result in loss of data transfer.

3
 Guide to Symbols

Guide to Symbols
This table describes the symbols that are found on the Model 7500FO. Detailed information about
functional symbols can be found in “Operating the Model 7500FO.”
Table 1: Symbols

Symbol Description

! Caution!

Consult Instructions for Use.

Follow Instructions for Use.

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

Magnetic Resonance (MR) Conditional

MR

MR Magnetic Resonance (MR) Unsafe

LA
SSIFIE UL Mark for Canada and the United States with respect to electric shock, fire, and
D
C

C UL US mechanical hazards only in accordance with:

• ANSI/AAMI ES60601-1:2005/(R)2012 and CAN/CSA-C22.2 No. 60601-1:14
• ISO 80601-2-61:2011, IEC 60601-1-8: 2006+A1:2012
CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning
medical devices.

SN Serial Number

Indicates separate collection for electrical and electronic equipment (WEEE).

EC REP Authorized Representative in the European Community.

Manufacturer

REF Catalogue number

QTY Quantity

Date of Manufacture

Country of Manufacture
US

Storage/Shipping Temperature Range

4
Guide to Symbols

Table 1: Symbols (Continued)

Symbol Description

RoHS Compliant (China)

Federal law (USA) restricts this device to sale by or on the order of a licensed
practitioner.
Protected against vertically falling water drops when enclosure is tilted up to
IPX2 15 degrees, per IEC 60529.

%SpO2 %SpO2 display.

Pulse Rate Display.

Numeric LEDs.

Alarm Bar LED.

Pulse Quality LED.

Sensor Alarm LED.

Pulse Strength Bargraph LED.

Alarm Silence LED.

AC Power Adapter LED.

Low Battery LED.

ON/STANDBY button.

Alarm Silence button.

Limits button.

Plus button.

Minus button.

Non-ionizing electromagnetic radiation. Equipment includes RF transmitters;

interference may occur in the vicinity of equipment marked with this symbol.

5
 Displays, Indicators and Controls

Displays, Indicators and Controls

This section describes the displays, indicators, and controls for the Model 7500FO.

Alarm
Silence %SpO2 Pulse Rate Alarm Bar
On/Standby Display Display
Speaker

Sensor Plus (+) Minus (-) Limits

Connector

Figure 1: Model 7500FO Front View

%SpO2 Display
The %SpO2 display is located on the left-hand side of the Model 7500FO front panel and is
identified by the %SpO2 symbol. This display shows blood oxygen saturation, from 0 to 100
percent. The numeric displays blink during SpO2 alarm conditions. See “Specifications” for sensor
accuracy information.

Pulse Rate Display

The pulse rate display is located on the right-hand side of the Model 7500FO front panel and is
identified by the symbol. This display shows the pulse rate in beats per minute, from 18 to
321. The numeric displays blink during pulse rate alarm conditions. See “Specifications” for sensor
accuracy information.

NOTE: LED means “light-emitting diode.”

Numeric LEDs
Green numeric LEDs display %SpO2 and pulse rate values. When setting the
device, these LEDs also display values for alarm limits, volume, and date and
time settings.

6
Displays, Indicators and Controls

Indicators and Icons

Alarm Bar LED
This LED indicates all alarm conditions. For high priority (patient) alarms, the
indicator is displayed in red, blinking fast. For medium priority alarms, the
indicator is displayed in amber, blinking slowly.

Pulse Quality LED

This amber LED blinks to indicate an inadequate pulse signal. If there is a sustained
period of poor quality signals, this LED will display a steady, constant light.

Sensor Alarm LED

This amber LED indicates when a sensor has become disconnected, has failed,
or is not compatible with this monitor.

NOTE: In the 7500FO, the Sensor Alarm LED latches. Sensor must be properly attached to
patient and alarm silence button must be toggled to clear LED.

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

Pulse Strength Bargraph LED

This 8-segment tricolor bargraph indicates pulse strength as determined by the
oximeter. The height of the Pulse Strength Bargraph LED is proportional to the
pulse signal, and the color is determined by pulse strength:
Green = a good pulse strength
Amber = a marginal pulse strength
Red = a low pulse strength, high priority alarm

Alarm Silence LED

This amber LED indicates that the audible alarm is silenced for two minutes
when it blinks. When alarms are active, this LED blinks in time with the alarm
bar. If no alarms are active, this LED flashes at the medium priority alarm rate.
When lit solid, the Alarm Silence LED indicates that audible alarm volumes are
set to less than 45 dB.

7
 Displays, Indicators and Controls

AC Power Adapter LED

This green LED is displayed when an external power supply is providing power
to the Model 7500FO.

NOTE: When the external power supply is disconnected, the device

automatically switches to battery power without loss of functionality.

Low Battery LED

This amber LED indicates a low battery charge when blinking, and a critical
battery charge when lit solidly. This LED does not indicate that the Model
7500FO is running on battery power.

WARNING: This device turns off after approximately 30 minutes when in low battery
mode.

Model 7500FO Front Panel Buttons

ON/STANDBY Button
Pressing this button once turns on the Model 7500FO. Holding this button for at
least 1 second shuts down the unit, putting it into Standby mode. In Standby
mode, all device functions are shut off, with the following exceptions:
• The AC Power Adapter LED is lit whenever the device is plugged in.
• Batteries are charged whenever the device is plugged in.
Momentarily pressing this button while the unit is on initiates an event marker.

Alarm Silence Button

This button toggles alarms between silenced and audible. Pressing the Alarm
Silence button silences the alarm for two minutes. Pressing it again (while
alarms are silenced) returns the alarms to their audible mode.

CAUTION: The two-minute alarm silence is automatically engaged at startup.

!

Limits Button
This button displays the upper and lower limits for alarm indications for SpO2
and heart rate measurements.
Pressing the Limits button allows users to access advanced menu options,
including adjusting alarm settings, alarm volume, and date and time settings. All
adjustments can be made using the Plus (+) and Minus (-) buttons.

8
Displays, Indicators and Controls

Plus (+) and Minus (-) Buttons

These buttons adjust values for many Model 7500FO functions. The Plus (+)
and Minus (-) buttons are used to adjust time, date, volume and upper and
lower alarm limits, except in Patient Security mode.

9
 Operating the Model 7500FO

Operating the Model 7500FO

NOTES:
• Before using the Model 7500FO, please review all contraindications, warnings and cautions.
• Before using the Model 7500FO, the battery must be charged for four (4) hours.
• When the Model 7500FO reaches critical battery, a medium priority alarm will sound. To clear
the alarm: charge the battery and turn the device off and back on.

Press the ON/STANDBY button. When the unit is first turned on, the Model 7500FO performs a
brief initialization sequence.
CAUTION: If the device does not beep during the initialization sequence, the
! speaker may not be functioning properly. Discontinue use until the situation is
corrected by Nonin Technical Service.

Verify that all LEDs illuminate and the unit beeps three times during the first phase of the
initialization sequence. If any LED is not lit (except the AC Power Adapter LED), do not use the
Model 7500FO. Contact Nonin Technical Service for assistance.
To verify that the Model 7500FO is functioning properly, it is important to monitor SpO2 and pulse
rate readings. Use the following procedure to verify that the sensor is working properly.
1. Ensure that the Model 7500FO is on, with the sensor connected.
2. Apply the pulse oximeter sensor (see sensor instructions for use).
3. Verify that a good SpO2 reading is displayed, that a pulse rate value appears, and that the
pulse strength bargraph LED is active.
WARNING: This device is intended only as an adjunct device in patient assessment. It
must be used in conjunction with other methods of assessing clinical signs and
symptoms.

WARNING: As with all medical equipment, carefully route patient cables and
connections to reduce the possibility of entanglement, strangulation, or injury to the
patient.

WARNING: Verify all alarm settings and limits during system startup to ensure that
they are set as intended.

10
Operating Instructions

Operating Instructions
Operating in the MR Environment
When operating the 7500FO in the MR (magnetic resonance) environment, observe the following
safety considerations:

Use only Nonin-branded 8000FC or 8000FI Fiber Optic Sensors. Do not use
MR cables or sensors that contain conductive wires.

The 7500FO and the connectors for the fiber optic contain ferrous material and
MR must be kept as far away from the magnet as possible at all times.

WARNING: To avoid injury or potential equipment damage, always keep the oximeter
and metal end of fiber optic cable beyond the distance of magnetic attraction. To ensure
safe operation of the 7500FO in the MR environment, the monitor must be located
outside the 200 Gauss line of the MR room and must be firmly attached to a fixed object.

MR Conditions
MR OPERATIONS: MR
USE ONLY NONIN Fiber Optic Sensors.
(Sensors containing electrical conductors will
cause patient burns).
The Model 7500FO must be kept outside the 200
Gauss line of the MR field and affixed to an
immovable object. Do not place on MR bed!
5682-000-04

MR WARNING: The battery charger cannot be used in the MR environment.

When operating the 7500FO in the MR environment, observe the following installation
recommendations:
• Install the 7500FO in the MR environment near the observation window or outside the MR
environment so the displayed values on the pulse oximeter may be clearly viewed. The 7500FO
monitor must also be firmly attached to a fixed object using the mounting hole (1/4-20 thread)
on the bottom of the device.
• If interference is suspected to the MR image or to the 7500FO, contact Nonin Technical Service
at (800) 356-8874, +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe) for assistance.

When operating the 7500FO inside the MR environment, operate the 7500FO on
MR battery power only. Remove the 7500FO from the MR environment to recharge
the batteries when the pulse oximeter is not in use.

11
 Operating Modes and Defaults

Operating Modes and Defaults

The Model 7500FO features Setup mode, Factory Defaults, User-Defined Defaults and Patient
Security modes.

NOTE: Patient Security mode overrides any default settings.

Setup Mode, Viewing Limits and Setting Time

In Setup mode, users can adjust alarm limits and volumes, set clock and calendar information and
clear the device’s memory. Pressing the Limits button activates Setup mode, and all adjustments
can be made using the Plus (+) or Minus (-) buttons. Setup mode is available when the device is
operating, or during the startup/initialization process. Time is set by adjusting each of the last five
options in setup mode: year, month, day, hour and minute.
Setup mode is not available in Patient Security mode. In Patient Security mode, pressing the
Limits button scrolls through the limits on the displays, allowing the operator to view the current
limits. Pressing and holding the Plus (+) button also reviews the limits, regardless of operating
mode.

Factory Defaults
In Factory Defaults, all adjustable parameters are set as indicated in the table below. This is the
Model 7500FO’s default operating setting.
The Model 7500FO is shipped with factory defaults active. To revert to factory default alarm limits
from the user-defined default alarm limits, simultaneously press the alarm silence and minus (-)
buttons.

NOTE: User-Defined Default values are lost when Factory Defaults are set active.

Table 2: Factory Default Settings

Alarm Limit Factory Default Adjustment Options Increment

SpO2 High Alarm Limit Off Off, 80-100 1%

SpO2 Low Alarm Limit 85% Off, 50-95 1%

Pulse Rate High Alarm Limit 200 BPM Off, 75-275 5 BPM

Pulse Rate Low Alarm Limit 50 BPM Off, 30-110 5 BPM

Alarm Volume High Off, Low, High N/A

Default alarm and volume settings are automatically selected for every operating session in which
the parameters were not recalled or changed within the setup menu.

12
Operating Modes and Defaults

User-Defined Defaults
In User-Defined Defaults, alarm limit and volume settings must be adjusted. To set the User-
Defined Defaults, set the alarm limits, hold the Alarm Silence button and then press the Limits
button. This sets the User-Defined Defaults to be the same as the current alarm limits.
The Model 7500FO recalls User-Defined Default settings at startup whenever this option is
selected. Once activated, User-Defined Defaults have priority over Factory Defaults.

NOTE: All user-defined default settings are retained even when both external and battery power
are lost.

Patient Security Mode

Alarm limits cannot be changed when the Model 7500FO is in Patient Security mode. Patient
Security mode prevents accidental changes to critical parameters. The Model 7500FO allows
users to lock and unlock alarm limits, volume settings, and time settings through the use of Patient
Security mode. Operators will notice several operating differences with Patient Security mode:
• Default and other previous device settings cannot be recalled.
• Clock and calendar data cannot be changed.
• SpO2 and pulse rate alarm limits and volumes cannot be changed. Pressing the Limits button
allows the operator to review the limits.
• Patient memory cannot be cleared.
• To put the device into Standby mode, the ON/STANDBY button must be held for at least
3 seconds.
• Memory playback not available.
Patient Security mode remains active when the device is turned off and then turned back on.
Patient Security mode is retained even when both external and battery power are lost.

NOTE: Turn on the device and verify Patient Security mode and settings after initiating Patient
Security mode.

When the Patient Security mode is enabled, operators cannot change SpO2, or Pulse Rate limits
or Alarm Volume—though it is still possible to view those settings. In Patient Security mode,
operators cannot view or set the time and date.
When the Model 7500FO is turned on in Patient Security mode, “SEC on” is displayed in the
display area, and three informational tones sound. The upper alarm limits are then displayed,
followed by the lower alarm limits.

NOTE: Patient memory cannot be cleared when this device is in Patient Security mode. In
addition, Patient Security mode is not disabled when the unit is turned off.

13
 Operating Modes and Defaults

Viewing and Changing Patient Security Mode

Enter Patient Security Mode – With the device off, press and hold the Alarm Silence button while
turning the device on.
Exit Patient Security Mode – With the device off, press and hold the Alarm Silence and Limits
buttons while turning the device on.
When the device is restarted, the Patient Security mode status is displayed on the Numeric LEDs
for 1 second:
• “SEC on” is displayed when Patient Security mode is enabled.
• “SEC 0FF” is displayed when Patient Security mode is disabled.

14
Operator Functions

Operator Functions
The Model 7500FO has several easy-to-use basic functions. Most involve pressing only a single
button.
Table 3: Basic Functions

Function Button Instruction

Turn the Model Press the ON/STANDBY button to turn on the Model
7500FO on and off. 7500FO. Press and hold the button for at least one
second to turn off the Model 7500FO. In Patient
Security mode, hold the ON/STANDBY button for
three seconds to turn off the Model 7500FO.

Initiate an event Momentarily press the ON/STANDBY button while

marker. the unit is on.

Mute the audible Momentarily press the Alarm Silence button.

alarms (2 minutes).

Change Pulse tone Momentarily press the Plus (+) button while the unit is
volume. in operating mode. Press again to sequence through
volume options for pulse tones.

Set alarm limits or Momentarily press the Limits button to step through
alarm volumes, clear the Limits menu. Use the Plus or Minus buttons to
memory or set clock. then or adjust alarm limits or selected volumes as desired.
When pressing Limits button, settings will appear in
the order shown in Table 4.

CAUTION: Review all limits to ensure they are appropriate for the patient.
!

CAUTION: Setting alarm limits to extremes can render the alarm system useless.
!
Table 4: Limits Display Sequence

Parameter Initial Setting (Pulse

Parameter Adjustment Range
(SpO2) Display Rate Display)

Recall Alarm Settings “rCL” “no” “yES” or “no”

Low %SpO2 Alarm Limit “02L” 2,3 “85” “0FF”, 50 to 95 by 1

Pulse High Alarm Limit “HH” 2 “200” “0FF”, 75 to 275 by 5

Pulse Low Alarm Limit “HL” 2 “50” “0FF”, 30 to 110 by 5

High %SpO2 Alarm Limit “02H” 2 “0FF” “0FF”, 80 to 100 by 1

15
 Operator Functions

Table 4: Limits Display Sequence (Continued)

Parameter Initial Setting (Pulse

Parameter Adjustment Range
(SpO2) Display Rate Display)

Alarm Volume “adb” 2 “Hi” “0FF” or “Lo” or “Hi”

Clear Memory “CLr” 1 “no” “yES” or “no”

Confirm Memory Clear “dEL” 1 “no” “yES” or “no”

Year “y” “00” 0 to 99 by 1

Month “nn” “00” 0 to 12 by 1

Day “d” “00” 1 to 31 by 1

Hour “h” “00” 0 to 23 by 1

Minutes “nn” “00” 0 to 59 by 1

Notes:
1) Both of these menu options are part of the memory clear command; “dEL” will be displayed only if
“yES” was selected as the setting for the “CLr” parameter.
2) These parameters are restored when Recall Alarm Settings is set to “yES.” These are also the settings
displayed by Review Alarm Settings.
3) The low SpO2 Alarm limit saved for recall cannot be lower than the current default for that alarm limit. If
it is, the default value will be used when alarm limits are restored.

The Model 7500FO features a number of advanced options, which are intentionally more difficult
to activate. These functions are recommended only for trained operators and require multiple
button presses to prevent accidental activation.
Table 5: Advanced Functions

Function Button Instruction

Recall Previous Press the Limits button while the unit is on. “rCL”
Alarm Limit appears, indicating that previous alarm limit
Settings settings may be recalled. To recall the settings,
press the Plus button and select “yES.” Press the
Limits button again to confirm.

Memory Playback Press and hold the Plus (+) button while turning on
the Model 7500FO. This functions with the Nonin
+ nVISION® software. Select the Model 7500 option
in nVISION software.

16
Operator Functions

Table 5: Advanced Functions (Continued)

Function Button Instruction

NOTE: Alarm limits cannot be changed when the Model 7500FO is in Patient Security mode.
Patient Security mode prevents accidental changes to critical parameters. The Model 7500FO
allows users to lock and unlock alarm limits, volume settings, and time settings.

Enter Patient To enter Patient Security mode, press and hold the
Security Mode Alarm Silence button while turning on the device.
+

Exit Patient To exit Patient Security mode, press and hold the
Security Mode Alarm Silence and Limits buttons while turning on
+ + the device.

Make Current To set the User-Defined Defaults to the current

Alarm Values alarm settings, hold the Alarm Silence button and
User-defined then press the Limits button.
Defaults +

Revert to Factory To revert to the factory defaults, from the User-

Defaults Defined Defaults alarm limits, hold the alarm
+ Silence button and then press the Minus (-) button.
NOTE: User-defined default values will be lost
when factory defaults are made active.

CAUTION: Review all limits to ensure they are appropriate for the patient.
!

17
 Care and Maintenance

Care and Maintenance

The advanced digital circuitry within the pulse oximeter of the Model 7500FO requires no
calibration or periodic maintenance other than battery replacement by Nonin Technical Service.
Field repair of the Model 7500FO circuitry is not possible. Do not attempt to open the Model
7500FO case or repair the electronics. Opening the case may damage the Model 7500FO and
void the warranty. If the Model 7500FO is not functioning properly, see “Troubleshooting.”
CAUTION: Follow local, state and national governing ordinances and recycling
! instructions regarding disposal or recycling of the device and device components,
including batteries. Use only Nonin-approved battery packs. Batteries might leak or
explode if used or disposed of improperly.

The OxitestPlus7 by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.

Cleaning the Model 7500FO

1. Clean the Model 7500FO with a soft cloth dampened with isopropyl alcohol, mild
detergent, or a 10% bleach (5.25% sodium hypochlorite) with water solution. Do not pour
or spray any liquids onto the Model 7500FO, and do not allow any liquid to enter any
openings in the device.
2. Allow the unit to dry thoroughly before reusing it.
WARNING: Do not use this device in or around water or any other liquid, with or
without AC power.

CAUTION: Do not immerse this device in liquid, and do not use caustic or abrasive
! cleaning agents on the device. Do not gas sterilize or autoclave this device. Do not
place liquids on top of this device.

Clean the Model 7500FO separately from its associated sensors. For instructions regarding
cleaning pulse oximeter sensors, refer to the appropriate pulse oximeter sensor package inserts.

18
Alarms and Limits

Alarms and Limits

The Model 7500FO is equipped with audio and visual alarm indicators to alert the operator to
provide immediate patient attention or to abnormal device conditions.
The intended operator’s position for correctly perceiving a visual alarm signal and its priority is
1 meter (3.3 feet), per IEC 60601-1-8.

High Priority Alarms

High priority alarms require immediate attention to the patient. They include SpO2, pulse rate, and
low perfusion alarms. On the Model 7500FO, high priority alarms are indicated by a rapidly
blinking red Alarm Bar LED when the value is equal to or greater than the alarm limit. In addition,
the pulse strength bargraph LED illuminates a red segment to indicate low perfusion.
High priority alarms are sounded as follows: three beeps, pause, two beeps and a
10 second pause.

Medium Priority Alarms

Medium priority alarms signal potential problems with the equipment or other non-life-threatening
situations. On the Model 7500FO, medium priority alarms are indicated with a slowly blinking
amber Alarm Bar LED.
Medium priority alarms are illuminated amber on the Alarm Bar LED and on the appropriate
indicator(s) or numeric displays, sometimes displaying an error code to help the user identify the
source of the error.
Medium priority alarms are sounded as three beeps and a 25-second pause.

Watchdog Alarms
Watchdog alarms are loud, two-tone, steadily beeping signals that indicate a hardware or software
malfunction. When a watchdog alarm is activated, it can be cleared by shutting down the Model
7500FO. If the watchdog alarm cannot be cleared, remove power and contact your distributor or
Nonin Technical Service.

Informational Tones
Informational tones communicate important information. They are typically single beeps or a
series of three beeps. Informational tones include the startup/initialization tone and the pulse rate
tone (which changes in pitch with SpO2 values: higher tones for higher SpO2, and lower tones for
lower SpO2).

19
 Alarms and Limits

Alarm Summary
The Model 7500FO detects both patient and equipment alarms. In general, patient alarms are
identified as high priority, while equipment alarms are identified as medium priority. High priority
alarms always take priority over medium priority alarms. Alarm indicators remain active for as long
as the alarm condition is present.

Patient Alarms
If patient SpO2 or pulse readings are equal to or above the upper alarm limit, or if they are equal
to or below the lower alarm limit, the device will signal a high priority alarm, indicated by numeric
LEDs flashing in sync with the red Alarm Bar LED.

Alarm Description Factory Default Adjustment Options Increment

SpO2 High Alarm Limit Off Off, 80-100 1%

SpO2 Low Alarm Limit 85% Off, 50-95 1%

Pulse Rate High Alarm Limit 200 BPM Off, 75-275 5 BPM

Pulse Rate Low Alarm Limit 50 BPM Off, 30-110 5 BPM

Low Perfusion Alarm Red segment on Pulse Strength Bargraph indicates low pulse
amplitude.

Equipment Alarms
Alarm Description Visual Indicator

Low Battery Alarm Battery LED blinks in sync with Alarm Bar LED. This alarm
signifies that the battery has less than 30 minutes of normal
operation. When Critical Low Battery is reached, the device’s
oximetry functions are disabled.

Sensor Alarm Sensor Alarm LED blinks in sync with Alarm Bar LED. This
alarm signifies a sensor fault or disconnect.

Other Equipment Alarms Error code appears in main display area.

20
Reviewing and Setting Volume and Alarm Limits

Reviewing and Setting Volume and Alarm Limits

NOTE: Alarm limits reset themselves to default values each time the unit is powered up—unless
the unit is in Patient Security mode. In Patient Security mode, alarm limits and volumes cannot
be adjusted; they can only be viewed.

WARNING: To comply with relevant product safety standards, ensure that all alarm
volumes are set appropriately and are audible in all situations. Do not cover or
otherwise obstruct any speaker openings.

Reviewing, Setting, or Changing Volumes and Alarm

Limits
1. Ensure that the device is on.
2. Press the Limits button until the limit you want to view or change is displayed.
• The current limit appears in the %SpO2 display.
• The current setting appears in the pulse rate display.
• Continue to press the Limits button until the limit you want to change is displayed.
3. To change the displayed value, press the Plus (+) or Minus (-) buttons as desired.
4. Continue to press the Limits button until the unit returns to normal operation.

CAUTION: Review all limits to ensure they are appropriate for the patient.
!

Silencing Alarms
Press the Alarm Silence button to silence alarms for two minutes. The Alarm Silence LED blinks
at the medium priority alarm rate while alarms are temporarily silenced. If alarms are silenced
during active alarm conditions, the Alarm Silence LED blinks in time with the alarm bar.
The Alarm Silence LED will be lit solidly when the alarm volume is set to less than 45 dB. Audible
indicators can be turned off in the Limits menu, by selecting “0FF” in the corresponding Alarm
Volume menu option.

21
 Reviewing and Setting Volume and Alarm Limits

Recalling Previous Settings

The pulse oximeter includes a feature that allows recall of the operator-adjusted settings in use
when the device was last turned off. The following settings are recalled when this feature is
activated:
• SpO2 high and low alarm limits
• Pulse rate high and low alarm limits
• Alarm volume settings
Previous operator-adjusted settings can be recalled by pressing the Limits button while the unit is
on. “rCL” appears, indicating that previous alarm limit settings may be recalled. To recall the
settings, press the Plus button and select “yES.” Press the Limits button again to accept the recall
and return to normal operation.

CAUTION: Review all limits to ensure they are appropriate for the patient.
!

NOTE: The recalled value for the SpO2 low alarm will not be less than the current default.

Error Codes
This device includes error codes that indicate problems with the unit. Error codes are indicated by
“Err” in the %SpO2 display, and a capital “E” followed by a 2-digit code in the pulse rate display.
To correct error conditions, perform the following steps:
1. Turn the unit off and then back on again to remove the error code.
2. If the error persists, disconnect all power, and then reconnect the power and turn the unit
back on.
If the error still persists, note the error code and contact Nonin Technical Service at
(800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe).

22
Memory and Data Output Features

Memory and Data Output Features

The Model 7500FO provides real-time (serial) patient data output, as well as analog output signals
for SpO2, pulse rate and event markers.

Serial Patient Data Output

This device features real-time data output capabilities. The serial format includes an ASCII header
containing model number, time, and date information.
The device provides real-time data output capability via the serial connector port. The 7500 SC
cable, available from Nonin, may be used to connect the Model 7500FO to the receiving computer.
The information from the Model 7500FO is sent in an ASCII serial format at 9600 baud with 8 data
bits, 1 start bit, and 2 stop bits. Each line is terminated by CR/LF.
Data from the device are sent once per second in the following format:
SPO2=XXX HR=YYY

NOTE: Pressing the ON/STANDBY button will insert a “*” at the end of the corresponding printed
line to serve as an event marker.

Pin Number Pin Assignment

1 Analog Output, SpO2

2 No Connect

3 Serial Data Output

4 Analog Output, Pulse Rate

5 Ground

6 No Connect

7 Event Marker

8 No Connect

9 5V, 250 mA Accessory Power Supply

23
 Memory and Data Output Features

Analog Output
The Model 7500FO provides analog output signals for SpO2, pulse rate, and event markers. Each
output level conforms to the specifications shown below:
Output Specification

SpO2 Output Analog Range 0 - 1.0 VDC (representing 0-100%)

1.27 VDC (out of track)

Pulse Rate Output Analog Range 0 - 1.0 VDC (representing 0-300 BPM)
1.27 VDC (out of track)

Event Marker 0 VDC or 1.0 VDC nominal (representing an event).

Event marker high for SpO2 less than low alarm limit.

Analog Output Load Current 2 mA maximum

%SpO2 Analog Output Accuracy ±2%

Pulse Rate Analog Output Accuracy ±5%

Analog Output Calibration

Analog calibration signals that allow external device calibration are provided after initial power up,
and continue until the Model 7500FO begins tracking SpO2 and pulse rate readings. The
calibration routine ends when the system begins tracking signals. The calibration signal sequence
is as follows:
Time Interval Analog Signal
30 seconds 1.0 VDC
30 seconds 0.0 VDC
1 second 0.1 VDC
1 second 0.2 VDC
1 second 0.3 VDC
1 second 0.4 VDC
1 second 0.5 VDC
1 second 0.6 VDC
1 second 0.7 VDC
1 second 0.8 VDC
1 second 0.9 VDC
1 second 1.0 VDC
1 second 1.27 VDC
Repeat

24
Memory and Data Output Features

Memory Features
The Model 7500FO can collect and store 70 hours of continuous SpO2 and pulse rate information.
Data may be played back with data retrieval software (Nonin’s nVISION software is
recommended). If you wish to create your own software, contact Nonin for the data format.
The memory in the Model 7500FO functions much like an “endless loop” tape. When the memory
is full, the unit begins overwriting the oldest data with new data. Data is written in 4-minute
intervals.
CAUTION: If the entire memory is filled, portions of the oldest record will be
! overwritten when a new record begins.

Each time the Model 7500FO is turned on, the current time/date information (if the clock is set
properly) is stored in memory, starting a new recording session. Only recording sessions greater
than one minute in length are stored in memory.
Patient SpO2 and pulse rate are sampled every second. Every 4 seconds, the extreme value of
the 4-second sample period is stored. 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 one pulse per minute in the interval from 18 to 200 pulses per minute, and in
increments of 2 pulses per minute in the interval from 201 to 300 pulses per minute.
Patient data is retained even when both external and battery power are lost.

Clearing Patient Memory

Patient memory can be cleared using the Model 7500FO’s Setup mode. Press the Limits button
to enter Setup mode, and use the Limits button again to scroll through the device’s options until
Memory Clear is displayed. Select “Yes” or “No” using the Plus (+) or Minus (-) buttons to clear
patient memory, and then confirm your selection using the Limits button.

Playing Back Memory Data

The Model 7500FO has a Memory Playback feature, allowing stored data to be output through an
external serial connection. Playing back the data does not clear the data from memory.
1. With the unit off, connect the serial connector port of the Model 7500FO to the back of
your computer using the 7500 SC cable, which is available from Nonin.
2. Press and hold the Plus (+) button while briefly pressing the ON/STANDBY button.
3. Release the Plus (+) button. Playback mode will be shown on the SpO2 and Pulse Rate
displays until memory playback is completed.
4. When Memory Playback is complete, the device will return to normal operation.

NOTES:
• Patient memory cannot be cleared when the Model 7500FO is in Patient Security mode.
• If using nVISION software, select the Model 7500 option for model type.
• The event marker is not stored in the 7500FO memory.

25
 Memory and Data Output Features

Connecting the Device into a Medical System

Incorporating the device into a medical system requires the integrator to identify, analyze, and
evaluate the risks to patient, operators, and third parties. Subsequent changes to the medical
system after device integration could introduce new risks and will require additional analysis.
Changes to the medical system that must be evaluated include:
• Changing the system configuration
• Adding devices to or disconnecting devices from the system
• Updating or upgrading equipment connected to the system
Issues resulting from user-initiated system changes may include corruption or loss of data.

NOTES:
• Use of a multiple-socket outlet with multiple devices results in a Medical Electrical System.
• When using the serial port to connect the device to other equipment, follow each device’s
cleaning instructions.
• Verify all equipment connected to the device is suitable for the patient’s environment.

CAUTION: Failure of a network data coupling (serial cable/connectors) will result in

! loss of data transfer.

26
Parts and Accessories

Parts and Accessories

For more information about Nonin parts and accessories:
• Contact your distributor or Nonin at (800) 356-8874 (USA and Canada), +1 (763) 553 9968, or
+31 (0)13 - 79 99 040 (Europe).
• Visit www.nonin.com.
The following Nonin accessories function with the Model 7500FO. Detailed information regarding
specified sensor use (patient population, body/tissue, and application) can be found in the
respective sensor instructions.
Model Number/Name Description
Battery Pack Rechargeable NiMH Battery Pack
7500FO Manual Operator’s Manual for the Model 7500FO
MPP30M-004 Power supply, 30W, used with a 7600PCS power cord
7600PCS–US Power cord, North America
7600PCS–UK Power cord, United Kingdom
7600PCS–EU Power cord, European Union and South America
7600PCS–AU Power cord, Australia
7600PCS–JP Power cord, Japan
Pulse Oximeter Reusable Sensors
8000FC Adult Fiber Optic Pulse Oximeter Sensor
8000FI Infant/Pediatric Fiber Optic Pulse Oximeter Sensor
External Cables
7500SC 7500 serial output cable
Sensor Accessories
8000FW Adult Sensor Wrap
8000TW Infant/Pediatric Sensor Wrap
Other Accessories
nVISION nVISION software for Microsoft Windows® operating systems
Clamp Pole Mount Clamp

WARNING: The use of accessories, sensors, and cables other than those listed in this
manual may result in increased electromagnetic emission and/or decreased immunity
of this device.

WARNING: Use only Nonin-branded PureLight pulse oximeter sensors. These sensors
are manufactured to meet the accuracy specifications for Nonin pulse oximeters. Using
other manufacturers’ sensors can result in improper pulse oximeter performance.

CAUTION: Use the Model 7500FO only with power adapters supplied by Nonin
! Medical.

27
 Service, Support, and Warranty

Service, Support, and Warranty

A return authorization number is required before returning any product to Nonin. To obtain this return
authorization number, contact Nonin Technical Service:

Nonin Medical, Inc. Nonin Medical B.V.

13700 1st Avenue North Prins Hendriklaan 26
Plymouth, Minnesota 55441, USA 1075 BD Amsterdam, Netherlands

(800) 356-8874 (USA and Canada) +31 (0)13 - 79 99 040 (Europe)

+1 (763) 553-9968 (outside USA & Canada) Fax: +31 (0)13 - 79 99 042
Fax: +1 (763) 553-7807 E-mail: [email protected]
E-mail: [email protected]

nonin.com

CAUTION: This device is a precision electronic instrument and must be repaired by Nonin
! Technical Service. 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.

Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of one year from the
date of purchase, each Model 7500FO battery pack. Nonin warrants the pulse oximetry module of the Model
7500FO for a period of three years from the date of purchase. Extended warranties are available on most
Nonin pulse oximeter models. Please consult your local Nonin distributor for additional information.
Nonin shall repair or replace any Model 7500FO found to be defective in accordance with this warranty, free
of charge, for which Nonin has been notified by the purchaser by serial number that there is a defect,
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 7500FO 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. Nonin reserves the right to charge a fee for a warranty repair request
on any Model 7500FO that is found to be within specifications.
The Model 7500FO is a precision electronic instrument and must be repaired by Nonin Technical Service.
Accordingly, any sign or evidence of opening the Model 7500FO, field service by non-authorized personnel,
tampering, or any kind of misuse or abuse of the Model 7500FO, 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.

28
Troubleshooting

Troubleshooting
Problem Possible Cause Possible Solution

Model 7500FO will not The unit has no power. Plug in the AC adapter.
activate.

Model 7500FO does not The speaker may not be Contact Nonin Technical Service for
beep during initialization functioning properly. repair or replacement.
sequence.

Model 7500FO will not The battery pack is not charged. Plug in the Model 7500FO AC Adapter to
operate on batteries. charge the battery pack.

The battery pack is inoperable. Contact Nonin Technical Service for

repair or replacement.

Unable to obtain a green The patient pulse strength is Reposition the finger or insert a different
pulse display on the indiscernible or perfused poorly. finger, and keep the sensor motionless
bargraph. for at least 10 seconds.

Warm the patient’s finger by rubbing or

covering with a blanket.
NOTE: In some instances, Position the sensor at a different site.
patient perfusion may be
inadequate for pulse Circulation is reduced because of Allow the hand to rest comfortably
detection. excess pressure on the sensor without squeezing or pressing the sensor
(between the sensor and a hard on a hard surface.
surface) after inserting finger.

The finger is cold. Warm the patient’s finger by rubbing or

covering with a blanket.

Position the sensor at a different site.

The sensor is applied incorrectly. Apply the sensor correctly.

There is possible interference Reduce or eliminate any interference.

from one of the following sources: Make sure that the sensor is not placed
• arterial catheter on the same arm being used for other
• blood pressure cuff patient therapies or diagnostics (e.g.,
• electrosurgical procedure blood pressure cuff).
• infusion line

The red LED is not lit in the Ensure the sensor is securely attached to
sensor’s finger insertion area. the Model 7500FO.

Check the sensor for any visible signs of

deterioration.

Contact Nonin Technical Service.

29
 Troubleshooting

Problem Possible Cause Possible Solution

Frequent or steady pulse There is excessive ambient light. Shield the sensor from the light source.
quality indication.
The Model 7500FO is applied to a Apply the sensor to a finger without
polished or artificial fingernail. artificial or polished nails.

Position the sensor at a different site.

The red LED is not lit in the Ensure the sensor is securely attached to
sensor’s finger insertion area. the Model 7500FO.

Check the sensor for any visible signs of

deterioration.

Contact Nonin Technical Service.

Excessive patient motion. Reduce patient motion.

A dash (-) appears in the An inadequate signal from the Reposition finger or insert a different
%SpO2 display. finger is being detected. finger, keeping sensor motionless for at
least 10 seconds.

Position sensor at different site.

The finger was removed from the Reinsert the finger and keep the sensor
sensor. motionless for at least 10 seconds.

The Model 7500FO is not Turn the unit off, check all connections,
functioning. and retry.

Contact Nonin Technical Service.

An error code appears in The Model 7500FO encountered Turn the unit off and then back on again
the display area. an error. to remove the error code.
If the error persists, disconnect all power,
and then reconnect the power and turn
the unit back on.
If the error still persists, note the error
code and contact Nonin Technical
Service.

The unit is in Alarm mode, The 2-minute Alarm Silence Press the Alarm Silence button to re-
but no audible alarms can button is activated. engage alarm volume, or wait for two
be heard. minutes. After two minutes, alarm tones
will automatically re-engage.

Audible volume set to “0FF” in Adjust volume through setup mode

alarm limits.

The Model 7500FO does not The battery is low. Recharge the battery.
record data.
The battery is missing. Contact your distributor or Nonin
Technical Service for repair or
replacement.

If these solutions do not correct the problem, please contact Nonin Technical Service at
(800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe).

30
Technical Information

Technical Information
NOTE: This product complies with ISO 10993-1, Biological 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 least IEC Standard EN 60950, IEC 62368-1, or UL 1950
for data-processing equipment.

WARNING: Portable RF communications equipment such as cell phones or radios

(including peripherals such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the ME system, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.

Manufacturer’s Declaration
Essential Performance
Essential Performance of the 7500FO Oximetry System includes SpO2 Accuracy, Pulse Rate
Accuracy, and Limit Alarm Conditions or generation of a Technical Alarm Condition. Accuracies or
alarms may be affected as a result of exposure to electromagnetic disturbances that are outside
of the environments listed in the Indications For Use. If issues are experienced, move Nonin
system away from the source of electromagnetic disturbances.
Refer to the following table for specific information regarding this device’s compliance to
IEC 60601-1-2.

Table 6. Electromagnetic Emissions

Emissions Test Compliance

This device is intended for use in the electromagnetic environment specified in the Indications For Use.
The user of this device should ensure that it is used in such an environment.

RF Emissions
Group 1, Class B
CISPR 11

Harmonic Emissions
Class A
IEC 61000-3-2

Voltage Fluctuations/Flicker Emissions

Complies with IEC 61000-3-3
IEC 61000-3-3

31
 Technical Information

Table 7. Electromagnetic Immunity

Immunity Test Compliance Level

This device is intended for use in the electromagnetic environment specified in the Indications For Use.

Electrostatic Discharge (ESD) ±8 kV contact

IEC 61000-4-2 ±15 kV air

Electrical Fast Transient/Burst ±2 kV for power supply lines

IEC 61000-4-4 ±2 kV for input/output lines

Surge ±0.5kV, ±1kV, ±2kV for Line-to-Ground

IEC 61000-4-5 ±0.5kV, ±1kV for Line-to-Line

Voltage dips, short interruptions, and 0% UT for 0.5 Cycles at 50 Hz at 0, 45, 90, 135, 180, 225,
voltage variations on power supply and 315° Phase
input lines 0% UT for 1 Cycle at 50 at 0°Phase
IEC 61000-4-11 70% UT for 25 Cycles at 50 Hz at 0°Phase
0% UT for 250 cycles at 50 Hz at 0°Phase
Power Frequency (50/60 Hz) Magnetic 30 A/m
Field
IEC 61000-4-8

Conducted RF IEC 61000-4-6 150 kHz to 80 MHz 3 Vrms

ISM and Amateur radio bands 6 Vrms

between 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3 80 MHz – 2.7 GHz 10 V/m

380 – 390 MHz 27 V/m

430 – 470 MHz 28 V/m

704 – 787 MHz 9 V/m

800 – 960 MHz 28 V/m

1.7 – 1.99 GHz 28 V/m

2.4 – 2.57 GHz 28 V/m

5.1 – 5.8 GHz 9 V/m

Note: UT is the AC mains voltage before application of the test level.

32
Technical Information

Equipment Response Time

If the signal from the sensor is inadequate, the last measured SpO2 and pulse rate values freeze
for 10 seconds and are then replaced with dashes.

SpO2 Values Average Latency

Standard/Fast Averaged SpO2 4 beat exponential 2 beats

Pulse Rate Values Response Latency

Standard/Fast Averaged Pulse Rate 4 beat exponential 2 beats

Equipment Delays Delay

Display Update Delay 1.5 seconds

Alarm Signal Generation Delay 0 seconds

33
 Technical Information

Example - SpO2 Exponential Averaging

SpO2 decreases 0.75% per second (7.5% over 10 seconds)
Pulse Rate = 75 BPM
SaO2 Reference 4 Beat Average
100

95

90

85

SpO2
80

75

70

65

60

0.0

8.0

16.0

24.0

32.0

40.0

48.0

56.0

64.0

72.0

80.0
Tim e in seconds

Specific to this example:

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

Testing Summary
SpO2 accuracy, and low perfusion testing were conducted by Nonin Medical, Inc., as described
below:

SpO2 Accuracy Testing

During motion and no-motion conditions at an independent research laboratory, SpO2 accuracy
testing is conducted during induced hypoxia studies on healthy, male and female, non-smoking,
light- to dark-skinned subjects that are 18 years of age and older. The measured arterial
hemoglobin saturation value (SpO2) of the sensors is compared to arterial hemoglobin oxygen
(SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the
sensors in comparison to the co-oximeter samples measured over the SpO2 range of 70 - 100%.
Accuracy data is calculated using the root-mean-squared (Arms value) for all subjects, per
ISO 80601-2-61, Medical Electrical Equipment—Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use.

Low Perfusion Testing

This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude
settings at various SpO2 levels for the oximeter to read. The oximeter must maintain accuracy in
accordance with ISO 80601-2-61 for heart rate and SpO2 at the lowest obtainable pulse amplitude
(0.3% modulation).

34
Technical Information

Principles of Operation
Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue
and detects the fluctuating signals caused by arterial pulses. Well-oxygenated blood is bright red,
while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen
saturation of arterial hemoglobin (SpO2) from this color difference by measuring the ratio of
absorbed red and infrared light as volume fluctuates with each pulse.

Specifications
Oxygen Saturation Display Range: 0 to 100% SpO2
Pulse Rate Display Range: 18 to 321 pulses per minute (BPM)
Displays:
Pulse Quality: LED, amber
Sensor Alarm: LED, amber
Pulse Strength Bargraph: LED, bargraph, tri-color segments
Alarm Indicator: LED, bi-color
Alarm Silenced: LED, amber
Numeric Displays: 3-digit, 7-segment LEDs, green
Low Battery: LED, amber
a
SpO2 Accuracy (Arms) :
FO Sensor: 70-100% ± 2 digits
a
Pulse Rate Accuracy (Arms) :
No Motion: ±3 digits, 18-300 BPM
Low Perfusion: ±3 digits, 40-240 BPM
Alarm Volume: High: 75 dBA
Low: 64 dBA
Informational Tone Volume: High: 30 dBA
Low: 26 dBA
Measurement Wavelengths and Output Power:b
Red: 660 nm @ 0.8 mW maximum average
Infrared: 910 nm @ 1.2 mW maximum average
Memory: 70 hours (assuming continuous operation)
Temperature (Operating): 0 to 40 °C (32 to 104 °F)
Temperature (Storage/Transportation): -40 to 70 °C (-40 to 158 °F)
Humidity (Operating): 10 to 90% noncondensing
Humidity (Storage/Transportation): 10 to 95% noncondensing
a. ±1 Arms represents approximately 68% of measurements at zero bias.
b. This information is especially useful for clinicians performing photodynamic therapy.

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 Technical Information

Altitude (Operating): Up to 4,000 meters (13,123 feet)

Hyperbaric Pressure: Up to 4 atmospheres
Power Requirements:
Mains: 100-240 VAC 50-60 Hz
DC Input: 12 VDC 1.5A AC adapter (in MR use battery
operation only)
Internal Power:
Battery: 7.2 volt NiMH battery pack
Operating Life (fully charged battery): 30 hours minimum
Operating Life (when using 5V, 250 mA accessory
power supply [Pin 9]): 10 hours
Storage Life: 27 days minimum
Recharge Rate: 4 hours maximum
Dimensions: Approximately 219 mm (8.6”) W x 92 mm (3.6”) H x
142 mm (5.6”) D
Weight: Approximately 900 grams (2 lbs) with battery
Warranty: 3 years
Classification per ANSI/AAMI ES60601-1 and CAN/CSA-22.2 No. 60101-1:
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
Analog Outputs:
SpO2 Output Range: 0-1 VDC (0-100% SpO2,
1.27 VDC (no data)
Pulse Rate Output Range: 0-1 VDC (0-300 BPM),
1.27 VDC (no data)
Event Marker: 0 V (no event), 1 V (event occurred)
Accuracy: ±2% (SpO2), ±5% (Pulse Rate)
Load Current: 2 mA maximum

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