Nonin Onyx II 9550 Instructions For Use Manual

Instructions for Use

Onyx II Model 9550 Finger Pulse Oximeter
®

Indications for Use

®
The Nonin Onyx II Model 9550 Finger Pulse Oximeter is a small, lightweight,
portable device indicated for use in measuring and displaying functional oxygen
saturation of arterial hemoglobin (%SpO
poorly perfused. It is intended for spot-checking of adult and pediatric patients on
fingers (other than the thumb) between 0.3 – 1.0 inch (0.8 – 2.5 cm) thick. The
device's intended use environments include hospitals, clinics, long-term care
facilities, skilled nursing facilities, emergency medical services, and home
healthcare services.
Caution: Federal law (USA) restricts this device to sale by or on the order of a
licensed practitioner.
Contraindications
• Do not use the device in an MR environment, in an explosive atmosphere, or on infant or
neonatal patients.
• This device is not defibrillation proof per IEC 60601-1.
Warnings
• This device is intended only as an adjunct in patient assessment. It must be used in conjunction
with other methods of assessing clinical signs and symptoms.
• The device must be able to measure the pulse properly to obtain an accurate SpO
measurement. Verify that nothing is hindering the pulse measurement before relying on the
SpO measurement.
2
• Operation of this device below the minimum amplitude of 0.3% modulation may cause
inaccurate results.
• General operation of the device may be affected by the use of an electrosurgical unit (ESU).
• The use of accessories other than those specified in these instructions may result in increased
electromagnetic emission and/or decreased immunity of this device.
• 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.
• Keep the oximeter away from young children. Small items such as the battery door, battery,
and lanyard are choking hazards.
• Certain activities may pose a risk of injury, including strangulation, if lanyard should become
wrapped around your neck.
Cautions
!
• This device has no audible alarms and is intended only for spot-checking.
• 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:
• do not apply the pulse
oximeter on the same arm
as a blood pressure cuff,
arterial catheter or infusion
line(s) (IVs)
• excessive light, such as
sunlight or direct home
lighting
• excessive motion
• The device may not work when circulation is reduced. Warm or rub the finger, or re-position the
device.
• This device's display will go blank after 30 seconds of no readings or poor readings.
• In some circumstances, the device may interpret motion as good pulse quality. Minimize
patient motion as much as possible.
• Cardiogreen and other intravascular dyes may affect the accuracy of the SpO
• Clean the device before applying it to a new patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids
onto the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium
chloride or isopropyl alcohol.
• A flexible circuit connects the two halves. Do not twist or pull the flexible circuit or overextend
the device's spring.
• Do not hang the lanyard from the device's flexible circuit.
• A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.
• 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.
• Portable and mobile RF communications equipment can affect medical electrical equipment.
• Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device
will be stored for more than 30 days. Do not use different types of batteries at the same time.
Do not mix fully charged and partially charged batteries at the same time. These actions may
cause the batteries to leak.
• Follow local, state and national governing ordinances and recycling instructions regarding
disposal or recycling of the device and device components, including batteries.
• 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.
Symbols
Symbol
Consult Instructions for Use
Follow Instructions for Use
Caution!
!
Type BF Applied Part (patient isolation from electrical shock)
Not for Continuous Monitoring (no alarm for SpO
SN
Serial Number
Battery Orientation
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.
Non-ionizing electromagnetic radiation. Equipment includes RF
transmitters. Interference may occur in the vicinity of equipment marked
with this symbol.
Indicates separate collection for electrical and electronic equipment
(WEEE).
Authorized Representative in the European Community
EC
REP
Protected against vertically falling water drops when enclosure is tilted up
IPX2
to 15 degrees, per IEC 60529.
Protected against vertically falling water drops when enclosure is tilted up
IP32
to 15 degrees and ingress of solid foreign objects greater than 2.5 mm
(0.1 in.) diameter per IEC 60529.
RoHS Compliant (China)
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
www.nonin.com
) and pulse rate of patients who are well or
2
• moisture in the device • cardiogreen and other
• improperly applied device intravascular dyes
• finger is outside • carboxyhemoglobin
recommended size range • methemoglobin
• poor pulse quality • dysfunctional hemoglobin
• venous pulsations • artificial nails or fingernail
• anemia or low hemoglobin polish
concentrations
2
Definition of Symbol
)
2
+1 (763) 553-9968 (outside US and Canada)
+46 650 401500 (Europe)
(800) 356-8874 (US and Canada)

Installing Batteries

Two 1.5 volt AAA-size batteries power the 9550 for about 6,000 spot checks or
36 hours of operation. Nonin recommends using alkaline batteries (included with
each new device). When batteries are low, the numeric displays flash once per
second. Remove batteries if the device will be stored for more than 30 days.
Replace low batteries as soon as possible, using the instructions below.
NOTE: Rechargeable batteries may be used; however, they require more frequent
replacement.
1. Hold the 9550 as shown in figure A. To release the battery tray, press upward
2. Remove the old batteries from the battery tray. Dispose of the batteries properly.
3. Insert two new 1.5 volt AAA-size batteries. Follow the polarity markings (+ and -) as
4. Carefully guide the battery tray back onto the device. Press downward and push
5. Insert your finger into the device to verify operation. See the Activating the Onyx II
2
A
Activating the Onyx II 9550 and Verifying Operation
The device contains numeric Light-Emitting Diodes (LEDs) that display oxygen
saturation and pulse rate. A tricolor LED display (pulse quality indicator, shown at
left) provides a visual indication of the pulse signal quality, while blinking at the
corresponding pulse rate. This display changes colors to alert you to changes in
pulse quality that may affect the readings:
•
•
•
Activate the 9550 by inserting the patient's finger into the device. The device detects
Pulse
the inserted finger and automatically illuminates the displays. Correct positioning of
Quality
Indicator the device on the finger is critical for accurate measurements.
NOTE: While on the finger, do not press the device against any surface and do not
squeeze or hold it together. The internal spring provides the correct pressure;
additional pressure may cause inaccurate readings.
1. Insert the patient's finger, nail side up, into the 9550 until the fingertip touches the
2. Make sure the finger is lying flat (not on its side) and is centered within the device.
measurement.
3. If the device does not turn on, remove the finger and wait a few seconds before
When a finger is inserted, the device performs a brief startup sequence. Verify that
all LEDs illuminate during the startup sequence. If any LED is not lit, do not use the
9550; contact Nonin Customer Support for repair or replacement. After the startup
sequence, the device begins sensing the pulse (indicated by the blinking pulse
quality indicator). Allow the device to stabilize and observe about 4 seconds of
continuous green-colored pulse quality before relying on the displayed values. It is
common for the displayed values to fluctuate slightly over a period of several
seconds. If the pulse quality indicator blinks yellow or red, try another finger.
A minus sign (-) appears in the left-most digit of the %SpO
senses the finger has been removed. The last measured SpO
values display for 10 seconds while the device automatically turns off. The device
will automatically shut off (to conserve battery life) approximately 10 seconds after
the finger is removed, or after a 2-minute period of inadequate pulse signals.
Using the Lanyard and Carrying Case
A lanyard and carrying case are provided for convenience. The device will function
with or without the lanyard.
If lanyard use is desired, thread the lanyard as shown below.
Onyx II 9550 Care, Maintenance, and Cleaning
The advanced digital circuitry within the device requires no calibration or periodic
maintenance other than battery replacement. Field repair of the 9550 circuitry is not
possible. Do not attempt to open the case or repair the electronics. Opening the
case will damage the device and void the warranty. Do not open the 9550 more than
90°, and do not twist or pull on the device when cleaning.
Cleaning the Onyx II 9550
•
1. To clean, wipe the surfaces with a soft cloth dampened with a 10% bleach
2. Dry with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry.
Fax: +1 (763) 553-7807
EC REP
+46 650 401514 (Europe)
E-mail: info@nonin.com
Nonin and Onyx are registered trademarks of Nonin Medical, Inc.
infointl@nonin.se (Europe)
U.S. Patents 5,490,523; 5,792,052
and then pull outward slightly with the thumb.
illustrated in figure B. Proper positioning of the batteries is essential for operation.
inward slightly to re-secure the battery tray (figure C). Do not force it into place; it
fits only when properly positioned.
9550 and Verifying Operation section for more information.
B
Green indicates a good pulse signal.
Yellow indicates a marginal pulse signal.
Red indicates an inadequate pulse signal.
built-in stop guide.
For best results, keep the 9550 at the patient's heart or chest level.
reinserting it.
WARNING: Certain activities my pose a risk of injury, including
strangulation, if lanyard should become wrapped around your neck.
CAUTION: A flexible circuit connects the two halves. Do not twist or
!
pull the flexible circuit or overextend the device's spring. Do not hang
the lanyard from the device's flexible circuit.
CAUTIONS:
!
• Clean the device before applying it to a new patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids
onto the device.
Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium
chloride or isopropyl alcohol.
solution (household bleach [5.25% sodium hypochlorite]). Do not use undiluted
bleach or any cleaning solution other than those recommended here, as
permanent damage could result.
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
C
display when the device
2
and pulse rate
2
© 2012 Nonin Medical, Inc.
7750-101-03