Nonin 7500FO User manual

Operator’s Manual
Digital Pulse Oximeter
Model 7500FO
Model 7500FO
1
0123
English

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 55441-5443
USA
[phone]
[phone] (USA and Canada)
Fax [phone]
[e-mail]
www.nonin.com
Authorized EC Representative:
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
References to “NONIN” in this manual shall imply Nonin Medical, Inc.
NONIN, 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.
5934-001-03
CAUTION: Federal law (USA) restricts this device to sale by or on the order of
a licensed practitioner.
Consult Instructions for Use.
EC
REP

i
Contents
Guide to Symbols ...............................................................1
Indications for Use .............................................................3
Contraindications ......................................................................3
Warnings ...................................................................................3
Cautions ....................................................................................4
Displays, Indicators and Controls ....................................7
Operating the Model 7500FO ..........................................11
Operating Instructions .....................................................12
Operating in the MR Environment ...........................................12
Operating Modes and Defaults .......................................14
Setup Mode, Viewing Limits and Setting Time ........................14
Factory Defaults ......................................................................14
User-Defined Defaults .............................................................15
Patient Security Mode .............................................................15
Operator Functions ..........................................................17
Care and Maintenance .....................................................21
Cleaning the Model 7500FO ...................................................21
Alarms and Limits ............................................................22
High Priority Alarms ................................................................22
Medium Priority Alarms ...........................................................22
Watchdog Alarms ....................................................................22
Informational Tones ................................................................22
Alarm Summary ......................................................................23
Reviewing and Setting Volume and Alarm Limits .........24
Reviewing, Setting, or Changing Volumes and Alarm Limits ..24
Silencing Alarms .....................................................................24
Recalling Previous Settings ....................................................25
Error Codes .............................................................................25
Memory and Data Output Features ................................26
Serial Patient Data Output ......................................................26
Analog Output .........................................................................27
Memory Features ....................................................................28
Parts and Accessories .....................................................30
Service, Support, and Warranty ......................................32
Warranty ..................................................................................33
Troubleshooting ...............................................................34

ii
Technical Information ......................................................38
Manufacturer’s Declaration .....................................................38
Equipment Response Time .....................................................42
Testing Summary ....................................................................43
Specifications ..........................................................................44

1
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.”
Symbol Description
Caution!
Consult Instructions for Use.
Type BF Applied Part (Patient isolation from electrical shock).
Magnetic Resonance (MR) Conditional
Magnetic Resonance (MR) Unsafe
UL Mark for Canada and the United States with respect to
electric shock, fire, and mechanical hazards only in accordance
with UL 60601-1 and CAN/CSA C22.2 No. 601.1.
CE Marking indicating conformance to EC directive No. 93/42/
EEC concerning medical devices.
Serial Number
Indicates separate collection for electrical and electronic
equipment (WEEE).
Authorized Representative in the European Community.
IPX2 Protected against vertically falling water drops when enclosure is
tilted up to 15 degrees, per IEC 60529.
%SpO2%SpO2display.
Pulse Rate Display.
Numeric LEDs
!
MR
MR
C
L
A
S
S
I
F
I
E
D
U
S
CUL
0123
SN
EC
REP

2
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.
Symbol Description

3
Indications for Use
The NONIN®Model 7500FO Digital 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.
Contraindications
•Explosion Hazard: Do not use in an explosive atmosphere or in the presence
of flammable anesthetics or gasses.
•This device is not defibrillation proof per IEC 60601-1:1990 clause 17h.
•The battery charger cannot be used in the MR environment.
Warnings
•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.
•Oximeter readings of this device may be affected by the use of an
electrosurgical unit (ESU).
•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.
•Do not use a damaged sensor.
•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 or strangulation.
•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.

4
•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.
•This device is a precision electronic instrument and must be repaired 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.
•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.
Cautions
•This equipment complies with IEC 60601-1-2:2001 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.
•Portable and mobile RF communications equipment can affect medical
electrical equipment.
•If this device fails to respond as described, discontinue use until the situation
is corrected by qualified technical professionals.
•The sensor might not work on cold extremities due to reduced circulation.
Warm or rub the finger to increase circulation, or reposition the sensor.
Warnings (Continued)
!

5
•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.
•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.
•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.
•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.
•When using the 300PS-UNIV battery charger, ensure that the AC cord is
plugged into a grounded outlet.
•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).
• Data is written in four-minute intervals—so if the entire memory is filled,
portions of the oldest record will be overwritten when a new record begins.
Cautions (Continued)
!

6
• 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
- 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
- poor pulse quality
- venous pulsations
- anemia or low hemoglobin concentrations
- cardiogreen and other intravascular dyes
- carboxyhemoglobin
- methemoglobin
- dysfunctional hemoglobin
- artificial nails or fingernail polish
- a sensor not at heart level.
• 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 or UL 1950 for data-
processing equipment.
• Operation of this device below the minimum amplitude of 0.3% modulation
may cause inaccurate results.
• Review all limits to ensure they are appropriate for the patient.
• The two-minute alarm silence is automatically engaged at startup.
Cautions (Continued)
!

7
Displays, Indicators and Controls
This section describes the displays, indicators, and controls for the
Model 7500FO.
%SpO2Display
The %SpO2display is located on the left-hand side of the Model 7500FO
front panel and is identified by the %SpO2symbol. This display shows
blood oxygen saturation, from 0 to 100 percent. The numeric displays
blink during SpO2alarm conditions. See “Specifications” for sensor
accuracy information.
On/Standby
Alarm
Plus (+)
Minus (-) Limits
%SpO2
Display
Pulse Rate
Display
Alarm
Bar
Speaker
Sensor
Connector
Silence

8
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 %SpO2and pulse rate values. When
setting the device, these LEDs also display values for alarm limits,
volume, and date and time settings.
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.

9
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.
AC Power Adapter LED
This green LED is displayed when an external power supply is
providing power to the Model 7500FO.
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.

10
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 SpO2and 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.
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.
!

11
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.
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 SpO2and 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 SpO2reading 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 or
strangulation.

12
Operating Instructions
Operating in the MR Environment
When operating the 7500FO in the MR (magnetic resonance)
environment, observe the following safety considerations:
When operating the 7500FO in the MR environment, observe the
following installation recommendations:
Use only NONIN-branded 8000FC or 8000FI Fiber Optic Sensors. Do
not use cables or sensors that contain conductive wires.
The 7500FO and the connectors for the fiber optic contain ferrous
material and 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.
CONTRAINDICATION: The battery charger cannot be used in the
MR environment.
MR
MR
MR Conditions
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!
MR OPERATIONS:
5682-000-04
MR
MR

13
• 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 [phone] or [phone] for
assistance.
When operating the 7500FO inside the MR environment, operate the
7500FO on battery power only. Remove the 7500FO from the MR
environment to recharge the batteries when the pulse oximeter is not in
use.
MR

14
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.
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.
Alarm Limit
Factory
Default
Adjustment
Options Increment
SpO2High Alarm Limit Off Off, 80-100 1%
SpO2Low 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

15
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.
•SpO
2and 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.

16
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.
Viewing and Changing Patient Security Mode
To enter Patient Security mode, press and hold the Alarm Silence button
while turning on the device. To exit Patient Security mode, press and hold
the Alarm Silence and Limits buttons while turning on the device.
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 oFF” is displayed when Patient Security mode is disabled.