Masimo MightySat Manuel De L'utilisateur page 11

Bluetooth LE Wireless Technology Information
BLUETOOTH LE WIRELESS TECHNOLOGY INFORMATION
Modulation Type
Max. Output Power
Frequency Range
Antenna Peak Gain
Recommended Range
Radio Modes
USA
Canada
Europe
Environment
ITEM
Operating Temperature Range
Operating Humidity
Storage/Transport Temperature
Atmospheric pressure
Compliance
SAFETY COMPLIANCE
ANSI/AAMI 60601-1
CSA C22.2 No. 60601-1
IEC 60601-1
EN 60601-1
IEC 60601-1-6
IEC 60601-1-11
ISO 80601-2-61
CITATIONS
1. The Masimo SET Technology used in the MightySat Rx 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% SpO
laboratory co-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
2. The Masimo SET Technology used in the MightySat Rx 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% SpO against a laboratory co-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
2
3. The Masimo SET Technology used in the MightySat Rx 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 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 Rx 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 and Masimo's simulator with signal strengths of greater than 0.02% and 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.
GFSK
-1 dBm
2402 MHz - 2480 MHz
-7 dBi
~10 feet (~3 meters) line-of-sight
RADIO COMPLIANCE
Bluetooth LE
FCC ID: VKF-MSAT01A
FCC parts 15.207 and 15.247
IC-7362A-MSAT01A
RSS-210
EN 300 328
EN 301 489-17
5°C to 40°C
10% to 95% RH
-40°C to 70°C
540 mBar to 1060 mBar
EMC COMPLIANCE
IEC 60601-1-2, Class B
ISO 80601-2-61: Clause
202, 20 V/m radiated
immunity
DESCRIPTION
EQUIPMENT CLASSIFICATIONS
PER IEC 60601-1
Degree of Protection
against electric shock
Mode of Operation
Degree of Protection from
Liquid Ingress
Environment
11
Type BF applied part
Continuous
IP23, Protection from ingress of
particulates > than 12.5 mm and
ingress from spraying water.
Not for use in the presence of
flammable anesthetics
against a
2
8981C-eIFU-0620