Masimo Opioid Halo User Manual page 59

Delivery Medication
Method
IV Fentanyl Rx
Hydromorphone 16
Morphine
Oxycodone
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
Group 1
CISPR 11
RF Emissions
Class B
CISPR 11
Harmonic Emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions Complies
IEC 61000-3-3
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
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/ burst
IEC 61000-4-4
OIRD PPV
Events
Halo –
Level 1
14 13.2%
3.5%
9 6.3%
55 4.1%
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.
Suitable for use in all establishments, including domestic environments and those directly
connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
IEC 60601 Test Compliance Level
Level
+8 kV contact +5 kV contact
+15 kV air +15 kV air
+/- 2 kV for +/- 2 kV for power
power lines lines
+/- 1 kV for +/- 1 kV for input/
input/ output output lines
lines
Halo – Halo –
Level 2 Level 3
30.4% 84.6%
8.7% 29.3%
13.4% 40.0%
9.3% 31.0%
Electromagnetic Environment - Guidance
Floors should be wood, concrete, or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of a typical commercial
or hospital environment.
57
NPV
Halo – Halo –
Level 1 Level 2
100.0% 100.0%
100.0% 100.0%
100.0% 100.0%
100.0% 100.0%
Halo –
Level 3
99.8%
100.0%
99.8%
99.9%