Citations
1.
The Masimo SET Technology used in the MightySat Fingertip Pulse Oximeter has been validated for no
motion accuracy in human blood studies on healthy adult male and female volunteers with light to
dark pigmented skin in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory
co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation
which
encompasses 68% of the population.
2.
The Masimo SET Technology used in the MightySat Fingertip Pulse Oximeter has been validated for
motion accuracy in human blood studies on healthy adult male and female volunteers with light to
dark pigmented skin in induced hypoxia studies while performing rubbing and tapping motions, at 2 to
4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2
to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and
ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of
the population.
3.
The Masimo SET Technology used in the MightySat Fingertip Pulse Oximeter has been validated for low
perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator
with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations
ranging from 70 to 100%. This variation equals plus or minus one standard deviation which
encompasses 68% of the population.
4.
The Masimo SET Technology used in the MightySat Fingertip Pulse Oximeter has been validated for
pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2
simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the
population.
Symbols
The following symbols may be found on the product or packaging.
Symbol
Definition
Follow Instructions for Use
Consult Instructions for Use
Manufacturer
Date of Manufacture
Not for Continuous Monitoring (No Alarm for SpO2)
Type BF Applied Part
IP23
Protection from ingress of particulates > than 12.5 mm and ingress from spraying water
ETL Intertek certification. Conforms to ANSI/AAMI ES 60601-1 and certified to CAN/CSA STD C22.2 No. 60601-1
Wireless features can be used in member states with the restriction of indoor use in France
Not made with natural rubber latex
Polypropylene
Separate collection for electrical and electronic equipment (WEEE)
Storage/transport temperature and air pressure range
Non-Sterile
Body Weight
Federal Communications Commission (FCC) licensing
FCC ID, IC, IC Model
Identifies unit has been registered as a radio device
3148433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK,FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005,CAN/CSA C22.2 No. 60601-1:2008, and applicable
Particular, (ISO 80601-2-61:2011) and related Collateral (IEC 60601-1-11:2010) Standards
for which the product has been found to comply by Intertek.
© 2015 Masimo Corporation
Patents:
www.masimo.com/patents.htm
.
Masimo, Signal Extraction Technology, SET, and Signal I.Q. are federally registered trademarks of Masimo
Corporation.
All trademarks and/or copyrights are properties of their respective owners.
Guidance and Manufacturer's Declaration - Electromagnetic
Emissions
Guidance and Manufacturer's Declarations - Electromagnetic Emissions
The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should
assure that it is used in such an environment.
Emission Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Group 1
ME Equipment 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
Suitable for use in all establishments, including domestic
environments.
Guidance and Manufacturer's Declaration - Electromagnetic
Immunity
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should
assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment - Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
+6 kV contact
+8 kV air
+6 kV contact
+8 kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30%.
Power frequency (50 / 60 Hz)
magnetic field.
IEC 61000-4-3
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of typical location in a typical
hospital environment.
Radiated RF
IEC 61000-4-3
ISO 80601-2-61, Clause 202
20 V/m
80 MHz to 2.5 GHz
20 V/m
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2,5 GHz
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,
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:
Note 1
: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2
: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
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 ME
Equipment is used exceeds the applicable RF compliance level above, the ME Equipment should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Recommended Separation Distances
Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment
The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the
user of the ME Equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the ME Equipment as recommended below, according to the maximum output power of the
communication equipment.
Rated maximum output
power of transmitter
(W)
Separation Distance According to Frequency of Transmitter (m)
150 K Hz to 80 MHz
d = 1.17*Sqrt (P)
80 MHz to 800 MHz
d = 0.18*Sqrt (P)
800 MHz to 2.5GHz
d = 0.35*Sqrt (P)
0.01
0.12
0.018
0.035
0.1
0.37
0.057
0.11
1
1.17
0.18
0.35
10
3.7
0.57
1.1
100
11.7
1.8
3.5
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.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
