Nonin Onyx 3 - 9591 Handleiding

Nonin Diversen Onyx 3 - 9591

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111849-001-03
©2018 Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052; other patents pending.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
Website: www.nonin.com
Phone: +1 (763) 553-9968
(800) 356-8874 (US and Canada)
+31 (0)13 - 79 99 040 (Europe)
E-mail: info@nonin.com
infointl@nonin.com (Europe) MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
EC
REP
Nonin, Onyx and CorrectCheck are trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Continuaâ„¢, the Continua logo and Continua Certifiedâ„¢ are trademarks, service marks, or certification marks of the Continua Health Alliance.
Installing Batteries
Two 1.5 volt AAA-size batteries power
the device for about 2,000 spot checks
or 25 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.
WARNING: Before changing
batteries, make sure the device is
off and is not applied to a digit.
1. Hold the device as shown in
Figure 1. To release the device’s
battery tray, press upward and
then pull outward slightly with
the thumb.
.
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
illustrated in Figure 2. Proper
positioning of the batteries is essential
for operation.
4. Carefully guide the battery tray
back onto the device. Press
downward and then push
inward slightly to re-secure the
battery tray (Figure 3). Do not
force it into place; it fits only when
properly positioned.
5. Insert your finger into the
device to verify operation. See
the Activating the Onyx3 Device
and Verifying Operation section
for more information.
Activating the Model 9591 and
Verifying Operation
The device contains
an LCD screen that
displays oxygen
saturation, pulse
rate and respiration
rate. The multicolor
LCD display
provides a visual
indication of the
poor signal quality described in the
Display Symbols table.
Activate the device by inserting the
patient’s finger into the device. The
device detects the inserted finger and
automatically illuminates the display.
Correct positioning of 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 device until the
fingertip touches the built-in
stop guide.
2. Make sure the finger is lying flat
(not on its side) and is centered
within the device. For best
results, keep the device at the
patient’s heart or chest level.
3. If the CorrectCheck screen (see
Display Symbols table) displays,
slide finger further into device.
Correct positioning of the
finger is critical for accurate
measurements.
4. If the device does not turn on,
remove the finger and wait a
few seconds before reinserting
it.
When a finger is inserted, the device
performs a brief startup sequence.
Verify that the LCD screen illuminates
during the startup sequence. If any part
of the screen is not lit, do not use the
device; contact Nonin Technical
Service for repair or replacement.
After the startup sequence, the device
begins sensing the pulse. Allow the
device to stabilize and observe about 4
seconds before relying on the displayed
values. Continually verify operation. It
is common for the displayed values to
fluctuate slightly over a period of
several seconds. If the poor signal
quality indicator continually blinks, try
another finger.
A appears in the display when the
device senses the finger has been
removed. The last measured SpO2,
pulse rate and respiration rate 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.
Onyx3
Instructions for Use – English
Onyx®3 Model 9591 Finger Pulse Oximeter
Figure 1
Figure 2
Figure 3
If the device does not turn on or if it shuts off unexpectedly:
• Verify batteries are correctly inserted.
NOTE: If batteries are installed backwards, the unit will not function.
• The batteries are depleted. Replace batteries.
If the problem persists, remove the batteries and contact Nonin Technical Service.
The OxitestPlus7 by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.
Connection via Bluetooth Wireless Technology
When the Model 9591 is placed on the finger and turns on, it is ready for a Bluetooth wireless connection.
The 9591 stays in this mode until it is shut off or the Bluetooth radio turns off. The symbol is white when
the Bluetooth radio is on, green when the 9591 is connected, and flashes when there is a communication
error.
The Bluetooth symbol is useful for the product installer.
Due to the wide variety of wireless environments, the Bluetooth connection between the 9591 and the host
device must be tested before using the 9591’s Bluetooth capabilities.
Indications for Use
The Nonin® Model 9591 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check
device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin
(%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter
provides a non-invasive measurement of respiration rate, in breaths per minute.
For %SpO2, pulse rate, and respiration rate the 9591 is intended for use in professional healthcare and
home healthcare settings in adult and pediatric patients who are well or poorly perfused, with digits that
are between 0.3 – 1.0 inch (0.8 – 2.5 cm) thick.
Warnings
• Use the device within its designated range (approximately 10 m/32 ft, spherical radius, line of sight
when connected to a Bluetooth Smart Ready device). Moving outside this range may cause missing, lost,
and/or inaccurate data.
• 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.
• Inspect the device application site at least every 4 hours to ensure correct device alignment and skin
integrity. Patient sensitivity to the device may vary due to medical status or skin condition.
• Avoid excessive pressure to the device application site as this may cause damage to the skin beneath the
device.
• 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 SpO2 and respiratory rate
measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO2 and
respiratory rate measurement.
• 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).
• 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.
• Before changing batteries, make sure the device is off and is not applied to a digit.
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 and respiration rate. Factors that may degrade pulse oximeter performance or affect the
accuracy of the measurement include the following:
• Respiration rate provides an indicator of central ventilatory drive and not a direct indication that air is
moving through the upper airway. Always consider clinical signs and symptoms when assessing the
patient and before intervening.
• Respiration Rate should not be used on patients with significantly irregular cardiac rhythms (defined as
three or more events of irregularity observed within 30 seconds) because the presence of these irregular
cardiac rhythms may cause inaccurate respiration rate values or the loss of displayed respiration rate
information. Safety and effectiveness of Respiration Rate in patients with significantly irregular cardiac
rhythms have not been established. Use an alternate means of monitoring ventilatory status for patients
with significant cardiac dysrhythmia.
• Respiration rate may present inaccurate respiration rate values when respiration rate exceeds 50% of
heart rate. This situation, though rare, may occur under conditions including, but not limited to, any of
the following: patients with high respiration rate and low heart rate, patients taking beta blockers, or
patients with specific medical conditions such as sick sinus syndrome.
• 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 2 minutes 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.
• Clean the device before applying it to a 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.
• 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.
• 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.
• 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 including CT, diathermy, RFID, and electronic
article security systems 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.
• When using the device in the home, avoid exposing the device to lint and dust.
Symbols
NOTE: Where applicable, an additional label bearing your country radio communications license
information will appear on the side of your device. This is not a serial number or device identifier.
Display Symbols
Using the Lanyard
WARNING: Certain activities my pose a risk of injury, including strangulation, if lanyard
should become wrapped around your neck.
CAUTIONS:
!
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.
Model 9591 Care, Maintenance, and Cleaning
The advanced digital circuitry within the device requires no calibration or periodic
maintenance other than battery replacement. The device’s expected service life is 2 years.
Field repair of the device 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 Device more than 90°, and do not twist or pull on the device when cleaning.
Cleaning the Model 9591
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 into
the device.
•
Do not use caustic or abrasive cleaning agents, or any cleaning products containing ammonium
chloride.
1. To clean, wipe the surfaces with a soft cloth dampened with mild detergent, isopropyl alcohol or a
10% bleach 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.
2. Dry with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry.
Equipment Response Time
If the signal from the device is inadequate, the last measured SpO2, pulse rate and respiration rate values
freeze for 10 seconds and are then replaced with dashes.
Table 1: Equipment Response Time
Example: SpO2 Exponential Averaging
SpO2 decreases 0.75% per second; pulse rate = 75 BPM
The response of the 4-beat average is 1.5 seconds.
Testing Summary
SpO2 and respiration rate accuracy and low perfusion testing was conducted by Nonin Medical, Inc. as
described below.
SpO2 Accuracy Testing
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 aged 18 years and older.
The measured arterial hemoglobin saturation value (SpO2) of the device is compared to arterial
hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The
accuracy of the device is 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
and ISO 9919, Standard Specification for Pulse Oximeters for Accuracy.
Low Perfusion Testing
This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings of
various SpO2 levels. The device must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919
for pulse rate and SpO2 at the lowest obtainable pulse amplitude (0.3% modulation).
Respiration Rate Accuracy Testing
RR accuracy testing is conducted during spontaneous breathing studies on healthy, male and female, light-
to-dark-skinned subjects that are aged 18 to 50 years old. The measured fingertip respiratory rate value
(RRFT) of the device is compared to capnography based respiratory rate (RRCapno) value. The accuracy of
the device is in comparison to the capnography based values measured over during 30 minutes of stable
breathing.
Accuracy data is calculated using mean error for all subjects.
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. Additionally, the pulse oximeter uses variations in the pulse volume
fluctuation's amplitude, baseline shift, and timing to determine the respiratory rate.
Specifications
Oxygen Saturation Display Range: 0% to 100% SpO2
Pulse Rate Display Range: 18 to 321 beats per minute (BPM)
Respiration Rate Display Range: 2 to 80 breaths per minute
Declared Accuracy: The table below shows Arms values measured using the Model 9591 in a clinical study
in non-motion conditions:
Table 2: Accuracy - Finger
• applying 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
• moisture in the device
• improperly applied device
• digit is outside
recommended size range
• poor pulse quality
• patient talking
• respiration outside the
range of 3-44 breaths per
minute
• venous pulsations
• anemia or low hemoglobin
concentrations
• cardiogreen and other
intravascular dyes
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
• artificial nails or fingernail
polish
• residue (e.g., dried blood,
dirt, grease, oil) in the light
path
Symbol Definition Symbol Definition
Caution! Not for continuous monitoring (no
alarm for SpO2)
Follow Instructions for Use. Battery orientation
MR
MR unsafe
IP32
Protected against vertically falling water
drops when enclosure is tilted up to
15 degrees and ingress of solid foreign
objects greater than or equal to 2.5 mm
(0.1 in.) in diameter per IEC 60529.
Type BF Applied Part (patient
isolation from electrical shock)
UL Mark for Canada and the United
States with respect to electric shock,
fire, and mechanical hazards only in
accordance with IEC 60601-1,
UL 60601-1 and CAN/CSA-C22.2
No. 601.1.
SN Serial Number
BDA Bluetooth Device Address
CE Marking indicating conformance
to EC Directive No. 93/42/EEC
concerning medical devices.
+70C
-40C
Storage/shipping temperature range
Non-ionizing electromagnetic
radiation. Equipment includes RF
transmitters. Interference may occur in
the vicinity of equipment marked with
this symbol.
Handle with care
Keep dry
Federal law (USA) restricts this device
to sale by or on the order of a licensed
practitioner.
Date of Manufacture
Continua Certifiedâ„¢ signifies this
device meets Continua certification
testing requirements, which support
interoperability in personal health
devices (continuaalliance.org).
US
US
Country of Manufacture
Manufacturer
Indicates separate collection for
electrical and electronic equipment
(WEEE)
EC
REP
Authorized Representative in the
European Community
REF
REF
REF
REF
Catalogue number
QTY
QTY
Quantity
Symbol Description
Nonin’s CorrectCheck™ senses that the finger has not been correctly inserted. If you
see this symbol, slide finger further into device.
The number next to this symbol is the amount of oxygen in your blood (functional
oxygen saturation of arterial hemoglobin).
The number next to this animated symbol is your pulse rate. Pulse rate is the number of
times your heart beats per minute.
RR The number next to this symbol is Respiration Rate in breaths per minute.
– – – Dashes replace the readings when the Model 9591 is unable to detect a usable signal.
Bluetooth Symbols:
White symbol – Radio is on.
Green symbol – Model 9591 is connected.
Flashing symbol – Connection error. The radio will reset.
No symbol – Radio is off.
Poor signal. Steady your hand, reposition finger, warm finger by rubbing, or select a
different finger.
Low battery. Replace batteries.
Critical battery. Flashing indicator on full screen. The device will not work until the
batteries are replaced.
SpO2 Values Average Latency
Standard/Fast Averages SpO24 beat exponential 2 beats
Pulse Rate Values Response Latency
Standard/Fast Averages Pulse Rate 4 beat exponential 2 beats
Respiration Rate Values Response Latency
Fast Estimation of RR 3 breath average 20 Seconds
Average RR 9 breath average 45 Seconds
Equipment Delays Delay
Display Update Delay 1.5 seconds
Range Specified Oxygen
Saturation (Arms)
Finger Oxygen
Saturation (Arms)
95% Limits of
Agreement
Low Perfusion Oxygen
Saturation (Arms)
70 – 100% ± 2 ± 1.31 (-2.3 - 2.9) ± 2
70 – 80% ± 2 ± 1.62 (-1.7 - 3.7) ± 2
80 – 90% ± 2 ± 1.05 (-2.3 - 2.2) ± 2
90 – 100% ± 2 ± 1.18 (-2.4 - 2.4) ± 2
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441, USA
Website: www.nonin.com
Phone: +1 (763) 553-9968
(800) 356-8874 (US and Canada)
+31 (0)13 - 79 99 040 (Europe)
E-mail: info@nonin.com
infointl@nonin.com (Europe) MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
EC
REP
Nonin, Onyx and CorrectCheck are trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052
The Bluetooth® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
Continuaâ„¢, the Continua logo and Continua Certifiedâ„¢ are trademarks, service marks, or certification marks of the Continua Health Alliance.
111849-001-03
©2018 Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052; other patents pending.
Manufacturer’s Declaration
Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.
Table 3: Electromagnetic Emissions
Table 4: Electromagnetic Immunity
Table 5: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
Table 6: Recommend Separation Distances
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Bluetooth Wireless Technology Information
Bluetooth Compliance: Version 4.0 single mode low energy
Operating Frequency: 2.4 to 2.4835 GHz
Output Power: TX: +3 dBM
Operating Range: 10 meter radius (line of sight)
Network Topology: Star - bus
Operation: Slave
Model 9591
Antenna Type: Integrated chip type antenna
Modulation Type: Frequency Hopping Spread Spectrum
Data Rate: 1 Mbit/second
Data Latency: 6 ms
Data Integrity: Adaptive Frequency Hopping
24-bit CRC (cyclic redundancy check)
32-bit message integrity check
Data Format: Nonin Proprietary: Sends data packets once per second. Includes a second
counter that allows the host to detect if packets are missing and the device
to retransmit.
Bluetooth SIG Standard: Compliant with Bluetooth SIG Pulse Oximeter
Profile specifications adopted by Continua.
Quality of Service: This device uses Bluetooth Smart technology for wireless communications, which
allows for reliable communications in electrically noisy environments, and transmits physiological data. If
the connection is lost, the device will become available for a connection in a few seconds.
Bluetooth Profiles Supported: GATT-based Nonin Proprietary Oximeter Profile; GATT-based Bluetooth
SIG Pulse Oximeter Profile
Authentication and Encryption: Supported
Encryption Key Size: 128 bits AES (advanced encryption standard)
Bluetooth Security
The Bluetooth radio contained in the Model 9591 is a Bluetooth Smart single-mode, low-energy radio. Model
9591 supports an encryption key size of 128 bits. While the Model 9591 is in a Bluetooth connection, it will
be unavailable for other connections. Apart from the standard Bluetooth security measures, Nonin has two
non-standard security measures that are available.
Declaration of Conformity with FCC and Canadian Ministry of Health Rules for
Electromagnetic Compatibility
• Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota, 55441, declares under its sole
responsibility that Model 9591, to which this declaration relates, comply with part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1) this device may not cause harmful interference,
and (2) this device must accept any interference received, including interference that may cause
undesired operation.
• Ministry of Health (Canada), Safety Code 6: standards include a substantial safety margin designed to
ensure the safety of all persons, regardless of age and health. The exposure standard for wireless mobile
phones employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit
set by the FCC is 1.6W/kg.
Déclaration de conformité aux règles de la FCC et du ministère canadien de la Santé
en matière de compatibilité électromagnétique
• Nonin¬Medical, Inc., sise à 13700 1st¬Avenue¬North, Plymouth, Minnesota, 55441, assumant ses
pleines responsabilités, déclare que le modèle¬9591, auquel cette déclaration est liée, est conforme à
la partie¬15 des règles de la FCC. Le fonctionnement du système est sujet aux deux conditions
suivantes¬: (1) cet appareil ne peut pas causer d’interférences nuisibles et (2) cet appareil doit accepter
toute interférence reçue, y compris des interférences susceptibles de causer un fonctionnement
indésirable.
• Ministère de la Santé (Canada), Code de sécurité¬6¬: les normes incluent une marge de sécurité
substantielle visant à assurer la sécurité de toutes les personnes, indépendamment de leur âge et de
leur état de santé. La norme d’exposition pour les téléphones mobiles sans fil emploie une unité de
mesure connue sous le nom de «¬taux d’absorption spécifique¬» (SAR). La limite SAR définie par la
FCC est de 1,6¬W/kg.
Federal Communications Commission (FCC) Notice
This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to
part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses, and can radiate radio frequency
energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio
or television reception, which can be determined by turning the equipment off and on. The user is encouraged
to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the distance between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from the outlet where the receiver is
connected.
• Consult the dealer or an experienced radio/TV technician for assistance.
• RF Exposure: For body worn operation, to maintain compliance with FCC RF exposure guidelines, use
only accessories that contain no metallic components and provide a separation distance of 15 mm
(0.6 inches) to the body. Use of other accessories may violate FCC RF exposure guidelines and should
be avoided.
• The Model 9591 is designed and manufactured not to exceed the emission limits for exposure to radio
frequency (RF) energy set by the United States FCC. These limits are part of comprehensive guidelines
and establish permitted levels of RF energy for the general population. The guidelines are based on the
safety standards previously set by both U.S. and international standards bodies. This EUT has been
shown to be capable of compliance for localized specific absorption rate (SAR) for uncontrolled
environment/general population exposure limits specified in ANSI/IEEE Std. C95.1-2005 and has
been tested in accordance with the measurement procedures specified in FCC/OET Bulletin 65
Supplement C (2001) and IEEE Std. 1528-2003.
The FCC requires the user to be notified that any changes or modifications to this device that are not
expressly approved by Nonin Medical, Inc. may void the user’s authority to operate the equipment.
Emissions Test Compliance Electromagnetic Environment—Guidance
This device is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure that it is used in such an environment.
RF Emissions
CISPR 11 Group 1
This device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11 Class B
This device is suitable for use in all establishments,
including domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2 N/A
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
N/A
Immunity Test IEC 60601 Test Level Compliance
Level
Electromagnetic
Environment—Guidance
This device is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure that it is used in such an environment.
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, relative
humidity should be at least
30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines N/A
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode N/A
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
±5% UT (>95% dip in UT) for
0.5 cycle
±40% UT (60% dip in UT) for 5
cycles
±70% UT (30% dip in UT) for
25 cycles
<5% UT (>95% dip in UT) for 5
sec.
N/A
Mains power quality should
be that of a typical
commercial or hospital
environment.
Power Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: UT is the AC mains voltage before application of the test level.
Immunity Test IEC 60601
Test Level
Compliance
Level Electromagnetic Environment—Guidance
This device is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the device,
including cables, than the recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended Separation Distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80
MHz
N/A
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.7
GHz
3 V/m 80 MHz to 800 MHz
800 MHz to 2.7 GHz
Radiated RF per
ISO 9919 clause
36 and ISO 80601-
2-61 clause
202.6.2.3
20 V/m
80 MHz to 2.7
GHz
N/A
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the device is used exceeds the applicable RF compliance level above, the
device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTES:
•At 80 MHz and 800 MHz, the higher frequency range applies.
•These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
The following table details the recommended separation distances between portable and mobile RF
communications equipment and this device.
Essential Performance
The essential performance of this device is defined as SpO2 accuracy and pulse rate accuracy, or an
indication of abnormal operation. When SpO2 accuracy and pulse rate accuracy cannot be achieved
by the device, abnormal operation is indicated by the poor signal indicator. If this condition persists,
the device will also blank the measurement of the display with dashes.
d1.17P=
d2.33P=
This device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. Users of this device can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communication equipment (transmitters) and the device as recommended below,
according to maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
Rated Maximum Output
Power of Transmitter
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7
GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
d1.17P=
d1.17P=
d2.33P=
SpO2 Low Perfusion Accuracy (Arms)*: 70 to 100% ±2 digits
Pulse Rate Declared Accuracy Range (Arms)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 40 to 240 BPM ±3 digits
Respiration Rate Accuracy: (Mean Error): 3-44 ± 1 Breath per minute
Measurement Wavelengths and Output Power**:
Red: 660 nanometers @ 0.8 mW max. average
Infrared: 910 nanometers @ 1.2 mW max. average
Temperature:
Operating: 23 °F to 104 °F (-5 °C to 40 °C)
Storage/Transportation: -40 °F to 158 °F (-40 °C to 70 °C)
Time (from storage) for device to be ready for its intended use:
3 minutes to warm from -40 °C to -5 °C
5 minutes to cool from 70 °C to 40 °C
Humidity:
Operating: 10% to 95% non-condensing
Storage/Transportation: 10% to 95% non-condensing
Altitude:
Operating: Up to 13,123 feet (4,000 meters)
Hyperbaric Pressure: Up to 4 atmospheres
Battery Life:
Operating: Approximately 2,000 spot checks, or 25 hours of continuous
operation using new alkaline batteries.
Storage: 1 month, with batteries installed. CAUTION: Remove
batteries if the device will be stored for more than 30 days.
Classifications per IEC 60601-1/UL 60601-1 / CAN/CSA-C22.2 No. 601.1:
Degree of Protection: Type BF-Applied Part
Enclosure Degree of Ingress Protection:
IP32
Mode of Operation: Continuous
This product complies with ISO 10993-1, Biological evaluation of medical devices – Part 1:
Evaluation and testing.
This device is not made with natural rubber latex.
This product complies with RoHS.
This product complies with REACH.
* ±1 Arms represents approximately 68% of measurements.
** This information is especially useful for clinicians performing photodynamic therapy.
Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period
of 2 years from the date of purchase, each Model 9591 exclusive of the batteries, spring,
lanyard, and lanyard lock.
Nonin shall repair or replace any Model 9591 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 notification occurs within the applicable warranty period. This
warranty shall be the sole and exclusive remedy by the purchaser hereunder for any Onyx3
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 9591 found to be within specifications.
Onyx3 9591 is a precision electronic instrument and must be repaired by trained Nonin
personnel only. Any sign or evidence of opening the Model 9591, field service by non-
Nonin personnel, tampering, or any kind of misuse of the Model 9591, shall void the
warranty. All non-warranty work shall be done at Nonin's standard rates and charges in
effect at the time of delivery to Nonin.
This graph shows plots of the error (SpO2 – SaO2) by SaO2 using the Model
9591 with a linear regression fit and upper 95% and lower 95% limits of
agreement. Each sample data point is identified by subject from a clinical
study in non-motion.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA
(800) 356-8874 (USA/Canada)
+1 (763) 553-9968 (outside USA and
Canada)
E-mail: technicalservice@nonin.com
www.nonin.com
Nonin Medical B.V.
Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands
+31 (0)13 - 79 99 040 (Europe)
E-mail: technicalserviceintl@nonin.com
d 1.17 P=

Product specificaties

Merk: Nonin
Categorie: Diversen
Model: Onyx 3 - 9591

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