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% U
T
(>95% dip in U
T
) for
0.5 cycle
±40% U
T
(60% dip in U
T
) for 5
cycles
±70% U
T
(30% dip in U
T
) for
25 cycles
<5% U
T
(>95% dip in U
T
) 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: U
T
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 survey
a
,
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:
SpO
2
Low Perfusion Accuracy (A
rms
)*: 70 to 100% ±2 digits
Pulse Rate Declared Accuracy Range (A
rms
)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (A
rms
)*: 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 A
rms
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 (SpO
2
– SaO
2
) by SaO
2
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.
